0% found this document useful (0 votes)

160 views99 pages

Health Care Engineering Part I: Clinical Engineering and Technology Management

Uploaded by

Michael Herrera Galán

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

0% found this document useful (0 votes)

160 views99 pages

Health Care Engineering Part I: Clinical Engineering and Technology Management

Uploaded by

Michael Herrera Galán

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

You are on page 1/ 99

Series

Series
SeriesISSN:
ISSN:
ISSN:1930-0328
1930-0328
1930-0328

FRIZE
FRIZE
FRIZE
SSYNTHESIS
YNTHESISL
YNTHESIS LECTURES
ECTURES ONB
ECTURESON
ON BIOMEDICAL
IOMEDICALE
IOMEDICAL ENGINEERING
NGINEERING
NGINEERING
&C Mor gan&
Morgan & Cl
Claypool
aypool Publishers
Publishers

Health Care Engineering

Series
Series
SeriesEditor:
Editor:
Editor:John
John
JohnD.
D.
D.Enderle,
Enderle,
Enderle,University
University
Universityof
of
ofConnecticut
Connecticut
Connecticut

Health
Health Care
Care Engineering
Engineering
Part
Part I:I:Clinical
Monique
Monique
Clinical Engineering
MoniqueFrize,
Frize,
Engineering and
Frize,Carleton
Carleton
andTechnology
CarletonUniversity
University
Technology Management
Universityand
and
Management
andUniversity
University
Universityof
of
ofOttawa,
Ottawa,
Ottawa,Canada
Canada
Canada
Part
Part I:
I: Clinical
Clinical Engineering
Engineering
Part
Part
PartIIIof of
isisisfollowed
ofHealth
followed
followedby
Health
HealthCare
by
Care
CareEngineering
byexamples
examples
examplesof
Engineering
Engineeringdescribes
of
ofvarious
various
describes
describesthe
variousapproaches
approaches
the
approachesused
thehealth
health
healthcare
used
usedto to
care
caredelivery
tomeasure
measure
delivery
deliverysystems
systems
measurephysiological
systemsin
physiological
in
inCanada
Canada
physiologicalvariables
Canadaand
variables
variablesin in
and
andin in
inhumans,
inthe
humans,
the
theU.S.
humans,either
U.S.
U.S.This
This
either
This
eitherfor
for
for
and
and Technology
Technology Management
Management
the
the
thepurpose
purpose
purposeof of
ofdiagnosis
diagnosis
diagnosisor or
ormonitoring
monitoring
monitoringpotential
potential
potentialdisease
disease
diseaseconditions;
conditions;
conditions;aaabrief
brief
briefdescription
description
descriptionof of
ofsensor
sensor
sensortechnologies
technologies
technologies
isisisincluded.
included.
included.The The
Thefunction
function
functionand and
androlerole
roleof
of
ofthe
the
theclinical
clinical
clinicalengineer
engineer
engineerin in
inmanaging
managing
managingmedicalmedical
medicaltechnologies
technologies
technologiesin in
inindustrialized
industrialized
industrialized
and
and
andin in
indeveloping
developing
developingcountries
countries
countriesare are
arepresented.
presented.
presented.This This
Thisisisisfollowed
followed
followedby by
byaaachapter
chapter
chapteron on
onpatient
patient
patientsafety
safety
safety(mainly
(mainly
(mainlyelectrical
electrical
electrical

HEALTH CARE
HEALTH
safety
safety
safetyand and
andelectromagnetic
electromagnetic
electromagneticinterference);
interference);
interference);itititincludes
includes
includesaaasection
section
sectiononon
onhow
how
howto to
tominimize
minimize
minimizeliability
liability
liabilityand
and
andhowhow
howto to
todevelop
develop
develop
aaaquality
quality
qualityassurance
assurance
assuranceprogram
program
programfor for
fortechnology
technology
technologymanagement.
management.
management.The The
Thenext
next
nextchapter
chapter
chapterdiscusses
discusses
discussesapplications
applications
applicationsof of
oftelemedicine,
telemedicine,
telemedicine,
including
including
includingtechnical,
technical,
technical,social,
social,
social,and
and
andethical
ethical
ethicalissues.
issues.
issues.The
The
Thelast
last
lastchapter
chapter
chapterpresents
presents
presentsaaadiscussion
discussion
discussionon on
onthe
the
theimpact
impact
impactof of
oftechnology
technology
technology
on
ononhealth
health
healthcare care
careand
and
andthe the
thetechnology
technology
technologyassessment
assessment
assessmentprocess.
process.
process.

CARE ENGINEERING:
This
This
ThisisisisPart
Part
PartIIIof
of
ofaaatwo-part
two-part
two-partbook book
bookthat
that
thatconsolidates
consolidates
consolidatesmaterial
material
materialthat
that
thatsupports
supports
supportscourses
courses
courseson on
ontechnology
technology
technologydevelopment
development
development
and
and
andmanagement
management
managementissues issues
issuesin in
inhealth
health
healthcarecare
careinstitutions.
institutions.
institutions.It It
Itcan
can
canbebe
beuseful
useful
usefulfor
for
foranyone
anyone
anyoneinvolved
involved
involvedin in
indesign,
design,
design,development,
development,
development,

ENGINEERING: PART
or
ororresearch,
research,
research,whether
whether
whetherin in
inindustry,
industry,
industry,hospitals,
hospitals,
hospitals,or or
orgovernment.
government.
government.Part Part
PartII II
II(ISBN
(ISBN
(ISBN9781627050722)
9781627050722)
9781627050722)covers covers
coversResearch
Research
Research
and
and
andDevelopment
Development
Developmentin in
inthe
the
theHealth
Health
HealthCare Care
CareEnvironment.
Environment.
Environment. Monique
Monique Frize
Frize

PART II
About
About
AboutSYNTHESIs
SYNTHESIs
SYNTHESIs
This
This
Thisvolume
volume
volumeisisisaaaprinted
printed
printedversion
version
versionofof
ofaaawork
work
workthat
that
thatappears
appears
appearsinin
inthe
the
theSynthesis
Synthesis
Synthesis
Digital
Digital
DigitalLibrary
Library
Libraryof of
ofEngineering
Engineering
Engineeringandand
andComputer
Computer
ComputerScience.
Science.
Science.Synthesis
Synthesis
SynthesisLectures
Lectures
Lectures

MOR GAN
MOR
MOR
provide
provide
provideconcise,
concise,
concise,original
original
originalpresentations
presentations
presentationsof of
ofimportant
important
importantresearch
research
researchand
and
anddevelopment
development
development
topics,
topics,
topics,published
published
publishedquickly,
quickly,
quickly,in
in
indigital
digital
digitaland
and
andprint
print
printformats.
formats.
formats.For
For
Formore
more
moreinformation
information
information

GAN &CL
GAN
visit
visit
visitwww.morganclaypool.com
www.morganclaypool.com
www.morganclaypool.com
SSYNTHESIS
YNTHESIS L
LECTURES
ECTURES ON
ON

&CL AYPOOL
&CL
BBIOMEDICAL
IOMEDICAL E
ENGINEERING
ISBN:
ISBN:
ISBN: 978-1-60845-366-5
978-1-60845-366-5
978-1-60845-366-5
Mor
Mor
Morgan
gan
gan &
&Cl
Cl
Claypool
aypool
aypool Publishers
Publishers
Publishers NGINEERING

AYPOOL
AYPOOL
90000
90000
90000

w
w
www
www
w...m
m
mooorrrgggaaannnccclllaaayyypppoooooolll...cccooom
m
m
9
99781608
781608
781608453665
453665
453665
John
John
JohnD.
D.
D.Enderle,
Enderle,
Enderle,Series
Series
SeriesEditor
Editor
Editor
Health Care Engineering: Part I
Clinical Engineering and Technology Management
iii

Synthesis Lectures on
Biomedical Engineering
Editor
JohnD. Enderle, University of Connecticut

Lectures in Biomedical Engineering will be comprised of 75- to 150-page publications on

advanced and state-of-the-art topics that spans the field of biomedical engineering, from the atom
and molecule to large diagnostic equipment. Each lecture covers, for that topic, the fundamental
principles in a unified manner, develops underlying concepts needed for sequential material, and
progresses to more advanced topics. Computer software and multimedia, when appropriate and
available, is included for simulation, computation, visualization and design. The authors selected to
write the lectures are leading experts on the subject who have extensive background in theory,
application and design.
The series is designed to meet the demands of the 21st century technology and the rapid
advancements in the all-encompassing field of biomedical engineering that includes biochemical,
biomaterials, biomechanics, bioinstrumentation, physiological modeling, biosignal processing,
bioinformatics, biocomplexity, medical and molecular imaging, rehabilitation engineering,
biomimetic nano-electrokinetics, biosensors, biotechnology, clinical engineering, biomedical
devices, drug discovery and delivery systems, tissue engineering, proteomics, functional genomics,
molecular and cellular engineering.

Health Care Engineering: Part II: Research and Development in the Health Care Environment
Monique Frize
November 2013

Health Care Engineering: Part I: Clinical Engineering and Technology Management

Monique Frize
November 2013

Computer-aided Detection of Architectural Distortion in Prior Mammograms of Interval Cancer

Shantanu Banik, Rangaraj M. Rangayyan, J.E. Leo Desautels
January 2013
iv
Content-based Retrieval of Medical Images: Landmarking, Indexing, and Relevance Feedback
Paulo Mazzoncini de Azevedo-Marques, Rangaraj Mandayam Rangayyan
January 2013

Chronobioengineering: Introduction to Biological Rhythms with Applications, Volume 1

Donald McEachron
October 2012

Medical Equipment Maintenance: Management and Oversight

Binseng Wang
October 2012

Fractal Analysis of Breast Masses in Mammograms

Thanh M. Cabral, Rangaraj M. Rangayyan
October 2012

Capstone Design Courses, Part II: Preparing Biomedical Engineers for the Real World
Jay R. Goldberg
September 2012

Ethics for Bioengineers

Monique Frize
2011

Computational Genomic Signatures

Ozkan Ufuk Nalbantoglu and Khalid Sayood
2011

Digital Image Processing for Ophthalmology: Detection of the Optic Nerve Head
Xiaolu Zhu, Rangaraj M. Rangayyan, and Anna L. Ells
2011

Modeling and Analysis of Shape with Applications in Computer-Aided Diagnosis of Breast Can-
cer
Denise Guliato and Rangaraj M. Rangayyan
2011

Analysis of Oriented Texture with Applications to the Detection of Architectural Distortion in

Mammograms
Fábio J. Ayres, Rangaraj M. Rangayyan, and J. E. Leo Desautels
2010
v
Fundamentals of Biomedical Transport Processes
Gerald E. Miller
2010

Models of Horizontal Eye Movements, Part II: A 3rd Order Linear Saccade Model
John D. Enderle andWei Zhou
2010

Models of Horizontal Eye Movements, Part I: Early Models of Saccades and Smooth Pursuit
John D. Enderle
2010

The Graph Theoretical Approach in Brain Functional Networks: Theory and Applications
Fabrizio De Vico Fallani and Fabio Babiloni
2010

Biomedical Technology Assessment: The 3Q Method

PhillipWeinfurt
2010

Strategic Health Technology Incorporation

BinsengWang
2009

Phonocardiography Signal Processing

Abbas K. Abbas and Rasha Bassam
2009

Introduction to Biomedical Engineering: Biomechanics and Bioelectricity - Part II

Douglas A. Christensen
2009

Introduction to Biomedical Engineering: Biomechanics and Bioelectricity - Part I

Douglas A. Christensen
2009

Landmarking and Segmentation of 3D CT Images

Shantanu Banik, Rangaraj M. Rangayyan, and Graham S. Boag
2009

Basic Feedback Controls in Biomedicine

Charles S. Lessard
2009
vi
Understanding Atrial Fibrillation: The Signal Processing Contribution, Part I
Luca Mainardi, Leif Sörnmo, and Sergio Cerutti
2008

Understanding Atrial Fibrillation: The Signal Processing Contribution, Part II

Luca Mainardi, Leif Sörnmo, and Sergio Cerutti
2008

Introductory Medical Imaging

A. A. Bharath
2008

Lung Sounds: An Advanced Signal Processing Perspective

Leontios J. Hadjileontiadis
2008

An Outline of Informational Genetics

Gérard Battail
2008

Neural Interfacing: Forging the Human-Machine Connection

Susanne D. Coates
2008

Quantitative Neurophysiology
Joseph V.Tranquillo
2008

Tremor: From Pathogenesis to Treatment

Giuliana Grimaldi and Mario Manto
2008

Introduction to Continuum Biomechanics

Kyriacos A. Athanasiou and Roman M. Natoli
2008

The Effects of Hypergravity and Microgravity on Biomedical Experiments

Thais Russomano, Gustavo Dalmarco, and Felipe Prehn Falcão
2008

A Biosystems Approach to Industrial Patient Monitoring and Diagnostic Devices

Gail Baura
2008
vii
Multimodal Imaging in Neurology: Special Focus on MRI Applications and MEG
Hans-Peter Müller and Jan Kassubek
2007

Estimation of Cortical Connectivity in Humans: Advanced Signal Processing Techniques

Laura Astolfi and Fabio Babiloni
2007

Brain–Machine Interface Engineering

Justin C. Sanchez and José C. Principe
2007

Introduction to Statistics for Biomedical Engineers

Kristina M. Ropella
2007

Capstone Design Courses: Producing Industry-Ready Biomedical Engineers

Jay R. Goldberg
2007

BioNanotechnology
Elisabeth S. Papazoglou and Aravind Parthasarathy
2007

Bioinstrumentation
John D. Enderle
2006

Fundamentals of Respiratory Sounds and Analysis

Zahra Moussavi
2006

Advanced Probability Theory for Biomedical Engineers

John D. Enderle, David C. Farden, and Daniel J. Krause
2006

Intermediate Probability Theory for Biomedical Engineers

John D. Enderle, David C. Farden, and Daniel J. Krause
2006

Basic Probability Theory for Biomedical Engineers

John D. Enderle, David C. Farden, and Daniel J. Krause
2006
viii
Sensory Organ Replacement and Repair
Gerald E. Miller
2006

Artificial Organs
Gerald E. Miller
2006

Signal Processing of Random Physiological Signals

Charles S. Lessard
2006

Image and Signal Processing for Networked E-Health Applications

Ilias G. Maglogiannis, Kostas Karpouzis, and ManolisWallace
2006
Copyright © 2014 by Morgan & Claypool

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in
any form or by any means—electronic, mechanical, photocopy, recording, or any other except for brief quotations
in printed reviews, without the prior permission of the publisher.

Health Care Engineering: Part I: Clinical Engineering and Technology Management

Monique Frize, P. Eng., O.C.
www.morganclaypool.com

ISBN: 9781608453665 print

ISBN: 9781608453672 ebook

DOI 10.2200/S00540ED1V01Y201310BME050

A Publication in the Morgan & Claypool Publishers series

SYNTHESIS LECTURES ON BIOMEDICAL ENGINEERING #50
Series Editor: John D. Enderle, University of Connecticut

Series ISSN 1930-0328 Print 1930-0336 Electronic

Health Care Engineering: Part I
Clinical Engineering and Technology Management
Monique Frize
Carleton University and University of Ottawa

SYNTHESIS LECTURES ON BIOMEDICAL ENGINEERING #50

M
&C MORGAN & CLAYPOOL PUBLISHERS
xii

ABSTRACT
The first chapter describes the health care delivery systems in Canada and in the U.S. This is
followed by examples of various approaches used to measure physiological variables in humans,
either for the purpose of diagnosis or monitoring potential disease conditions; a brief description
of sensor technologies is included. The function and role of the clinical engineer in managing med-
ical technologies in industrialized and in developing countries are presented. This is followed by a
chapter on patient safety (mainly electrical safety and electromagnetic interference); it includes a
section on how to minimize liability and how develop a quality assurance program for technology
management. The next chapter discusses applications of telemedicine, including technical, social,
and ethical issues. The last chapter presents a discussion on the impact of technology on health care
and the technology assessment process.

KEYWORDS
Health care Canada and U.S., clinical engineering, sensor technologies, patient safety, telemedi-
cine, technology assessment.
xiii

Contents
Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

1 The Health Care System in North America (Canada and U.S.). . . . . . . . . . . . . . . ��1
1.1 Canada�� 1
1.1.1 Some Historical Facts�� 2
1.2 United States�� 4
1.3 Coverage and Access�� 5
1.4 Health Care Facilities �� 6

2 Measuring Physiological Variables in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . ��9

2.1 Common Measurements of Physiological Variables �� 9
2.1.1 The Heart�� 9
2.1.2 Non-Invasive Blood Pressure Measurements (NIBP) �� 11
2.1.3 Invasive Blood Pressure �� 12
2.1.4 Defibrillation �� 13
2.1.5 Pacing the Heart �� 14
2.1.6 The Brain �� 15
2.1.7 Electromyography (EMG)�� 16
2.1.8 Respiration�� 17
2.1.9 Measurement of Temperature �� 18
2.2 Transducers and Sensors �� 19
2.2.1 Characteristics of Physical Sensors�� 20
2.2.2 Chemical sensors�� 21
2.3 Gas Sensors�� 23

3 Management of Medical Technologies in Industrialized and Developing

Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.1 Evolution of Clinical Engineering in Industrialized Countries�� 27
3.2 Functions and Activities of Clinical Engineering Departments (CEDs) �� 31
3.2.1 In-House Medical Equipment Maintenance �� 31
3.2.2 Functions Usually Performed by Engineers�� 32
3.3 A Changing Role in the 21st century�� 35
3.4 Clinical Engineering in Developing Countries�� 36
xiv
3.4.1 A Model to Assess the Readiness of a Country to Acquire, Diffuse,
Manage Medical Technologies �� 38
3.4.2 Technology Management�� 40
3.4.3 WHO Baseline Country Survey on Medical Devices (2010) �� 41

4 Safety Considerations, Minimizing Liability, and Continuous Quality

Improvement (CQI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.1 Electrical Safety in Hospitals�� 45
4.2 Brief Summary of Electrical Safety Issues�� 46
4.2.1 Ensuring Electrical Safety �� 47
3.2.2 Electro-Magnetic Interference (EMI) and Medical Devices �� 47
4.3 Liability Exposure�� 50
4.3.1 How to Minimize Risk�� 50
4.3.2 Legal Issues in Clinical Engineering Practice �� 51
4.4 Quality Assurance and CQI �� 52
4.4.1 How to Measure QAA �� 53
4.4.2 General Goal �� 53
4.4.3 Examples of QA Measures for CEDs �� 54

5 Telemedicine: Applications and Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

5.1 Definitions�� 59
5.2 Drivers of the Technology �� 60
5.2.1 Technological Drivers�� 60
5.2.2 Non-Technological Drivers �� 60
5.2.3 Home Telecare�� 60
5.3 Medical Applications of Telemedicine�� 61
5.3.1 Examples of Medical Applications of Telemedicine�� 62
5.4 Report to the U.S. Congress (1997)�� 64
5.5 Evaluation Elements for Clinical Telemedicine�� 64
5.6 The Report on U.S. Telemedicine Activity by the Association of Telemedicine
Service Providers (ATSP) in 1998 �� 64
5.7 Report to the U.S. Congress (2001)�� 65
5.7.1 Barriers and Issues Concerning the Implementation and Use of Tele-
medicine�� 65
5.8 Ethical and Legal Aspects�� 66
5.9 Technical Requirements�� 67
xv
6 Impact of Technology on Health Care and the Technology Assessment
Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
6.1 Impact of Technology on Health Care �� 71
6.2 The Health Technology Assessment Process�� 73
6.2.1 What is a Health Technology Assessment (HTA)?�� 74

Author Biography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
xvii

Preface
The material for this Lecture Series arises from 20 years of teaching a course entitled “Health
Care Engineering.” My background was an undergraduate degree in Electrical Engineering at the
University of Ottawa, a Master of Philosophy in Electrical Engineering in Medicine at Imperial
College of Science and Technology in London (U.K.) and a doctorate at Erasmus Universiteit in
Rotterdam (The Netherlands) in clinical engineering. After the Master degree in London in 1970,
I taught two courses—bioinstrumentation and biomedical statistics—at Université du Québec à
Montréal for one term, then worked as a clinical engineer at Notre-Dame Hospital for eight years.
In this role, I developed the medical equipment management program and realized quickly how
engineers have a significant impact on the quality, effectiveness and safety of health care delivery. In
July 1979, I was appointed Head of the Regional Clinical Engineering Services for seven hospitals
in North-Eastern New-Brunswick. In 1989, after completing the doctoral degree, I was appointed
Professor in Electrical/Biomedical Engineering at the University of New Brunswick, where I devel-
oped the health care engineering course (Part I). In 1996, as Professor at Carleton University and
the University of Ottawa, I developed a second course for graduate students (Part II).
This book provides a basis on which other specialized courses can be built, such as signal
processing, medical imaging, data mining, processing, etc. It is useful for hospital administrators,
clinical engineers, and biomedical technicians who hold a direct or indirect role for technology
management in their institution. References and additional readings are provided for readers who
wish to have a more in-depth knowledge about each of the topics discussed.
Part II of this two-part series presents a brief discussion on the occurrence of adverse events
and medical errors and how information technology can help to reduce these. Chapter 2 discusses
issues related to electronic medical records. The next three chapters present the four steps in the
knowledge management process and illustrate these through examples taken from the perinatal
clinical environment. These steps include data acquisition, storage, and retrieval; knowledge discov-
ery; knowledge translation; and knowledge integration and sharing. Chapter 6 is a short discussion
on clinical trials and usability studies.
Both Part I and Part II of this Health Care Engineering book consolidate material that sup-
ports a course on medical technology management and research and development of technologies
in a health care environment. It can be useful for anyone involved in design, development, or re-
search, whether in industry, hospitals, government, or in universities and colleges. It is not intended
to cover all topics in depth but rather to provide an overview of the subjects and sources where
additional information can be found.
xviii PREFACE
It is helpful here to explain a few of the words used in the book. The term “biomedical tech-
nician” is used instead of biomedical technologist to differentiate between the medical functions
carried out by medical imaging technologists or respiratory technologists. Some biomedical tech-
nical employees have four years of technical education, which would label them as technologists,
but the term “technician” is used here to refer to people involved in the repair and maintenance of
equipment, as opposed to people operating it.
Another term that conjures up debates in the field is “medical device.” WHO defines med-
ical device as an: "article, instrument, apparatus or machine that is either used in the prevention,
diagnosis or treatment of illness or disease, or used for detecting, measuring, restoring, correcting
or modifying the structure or function of the body for some health purpose” (WHO, http://www.
who.int/medical_devices/technology_diffusion_24Jan12.pdf; last accessed September 2013). In
this book, the term “equipment” is used most frequently, but the term medical device is also used
in some places.
I am grateful to all the students who have provided interesting discussions in their essays
and class discussions. They have contributed positively to an improvement of the course over the
years. My hope is that they become responsible engineers, who design and develop technological
solutions with people, society, and our world in mind.
1

CHAPTER 1

The Health Care System in North

America (Canada and U.S.)
This chapter summarizes some of the important elements of the health care system in Canada and
the U.S. and is not intended to be comprehensive. Rather, the intent is to familiarize readers with
the main structure and funding of health care in these two countries. The latter part of the chapter
provides a brief description of health care institutions, to help engineers and technicians interface
with these organizations and their human resources while performing their biomedical work.
Canada and the U.S. had a similar health care system in the early 1960s, but in the past 50
years funding models in both countries have differed substantially. Canada's universal health care
services are covered to the level of about 70% by government. The Canada Health Act states that
all citizens are to be fully insured and will not have to disburse user fees for all medically necessary
hospital and physician care. About 91% of hospital expenditures and 99% of physician services are
financed by the public sector. However, ophthalmology and dental services account for much of
the private expenditures in Canada. The U.S. has a mixed public-private system and is one of two
Organization for Economic Co-operation and Development (OECD) countries not to have some
form of universal health coverage, the other being Turkey.

1.1 CANADA
Health Canada defines its role with regards to the Canadian Health care system:
Roles and responsibilities for Canada's health care system are shared between the fed-
eral and provincial-territorial governments. Under the Canada Health Act (CHA), the
federal health insurance legislation, criteria and conditions are specified that must be
satisfied by the provincial and territorial health care insurance plans in order for them to
qualify for their full share of the federal cash contribution, available under the Canada
Health Transfer (CHT). Provincial and territorial governments are responsible for the
management, organization and delivery of health services for their residents (Health
Canada, 2010).
There are 13 health systems in Canada, with common features and variations within the 10
provinces and 3 territories. The Government of Canada established basic national standards and
rules and contributes a share of the health care delivery costs carried out by the provinces, while the
latter oversee, plan, manage, and pay the lion share of the costs. What Canadians used to call Medi-
2 1. THE HEALTH CARE SYSTEM IN NORTH AMERICA (CANADA AND U.S.)
care consisted of the two historical agreements between the Government of Canada and the prov-
inces to cover all hospital costs and doctors’ visits. But with time, Medicare eventually incorporated
all health expenditures undertaken by each of the provinces. Exceptions that remained were drugs,
homecare, and dental care. In addition to the governments, there are other players: professional
associations, industries (pharmaceutical and medical devices), service agencies, Non-Governmental
Organizations, the Conference Board of Canada, the World Health Organization (WHO) in Ge-
neva, as well as their regional components such as the Pan American Health Organization (PAHO)
in the Americas (Washington) and a Regional Office for Europe (Copenhagen). The Organization
for Economic Cooperation and Development (OECD) with Headquarters in Paris also studies the
health systems of its members. The World Bank, located in Washington, Paris, and Tokyo, the In-
ternational Monetary Fund in Washington, and the International Labour Office (ILO) in Geneva
are other organizations involved in health care issues.
WHO states “Health systems consist of all the people and actions whose primary purpose is
to improve health. They may be integrated and centrally directed, but often they are not…” (WHO,
2000). The World Health Organization provides some comments on health systems in general:
They have contributed enormously to better health, but their contribution could be
greater still, especially for the poor. Failure to achieve that potential is due more to
systemic failings than to technical limitations. It is therefore urgent to assess current
performance and to judge how health systems can reach their potential (World Health
Organization, 2000).
In Canada, the health system consists of the interactions between three major players: Health
Canada and the Federal Government; the provincial Ministries of Health and their respective
governments; and organized medicine. No one is really in charge of the system, which rests on
the constantly renegotiated equilibrium between these key players. The system in Canada is not
“socialized medicine” but rather a “social insurance” system, as doctors are in the private sector and
Canadian hospitals are controlled by private boards and/or regional health authorities, rather than
being part of the government.
There is one important missing element in determining the future of health care in Canada:
the voice of patients and the public in general, both as citizens and as taxpayers. The only voice they
have is through a general election. This is a major imbalance in the power structure, the dynamics
of reforms, and the accountability mechanisms of the health care system.

1.1.1 SOME HISTORICAL FACTS

The Canadian Constitution of 1867 made HEALTH a provincial responsibility and this did not
change with the 1982 repatriation of the Constitution from Britain. The Constitution confirmed
the following direct responsibilities of the Federal Government: Veterans’ and Natives’ health care,
1.1. CANADA 3
drugs’ administration and regulations with respect to drugs, devices, etc. The Constitution (1982),
under its equalization provisions, obliges the provinces to provide comparable levels of public
service for comparable levels of taxation. The first public discussion of a Canadian Health Care
system occurred in 1919, on the platform of the Liberal Party of Canada. In 1945, there was a
Federal-Provincial Reconstruction Conference. The Minister of Health of Canada, Brooke Claxton,
proposed the National Health Grants Program, but this was opposed by Ontario (George Drew)
and Quebec (Maurice Duplessis). In 1948, this was re-submitted by the new Minister of Health
of Canada, Paul Martin, Sr. All provinces approved it and some funding was provided towards a
comprehensive health insurance program.
Just prior to this time, T.C. (Tommy) Douglas, the Premier of Saskatchewan, passed The
Saskatchewan Hospital Services Plan (1947). In 1957–58, the Federal Liberal government under
Paul Martin, Sr., followed with an offer of a 50–50 share (Federal-Provincial); this was accepted
by all as the Hospital Insurance and Diagnostic Services Acts (HIDS). In 1962, Saskatchewan was a
pioneer again, despite a dramatic doctors’ strike; it instituted The Saskatchewan Medical Care Insur-
ance Plan. In 1964, Mr. Justice Emmett Hall’s Commission set up by the opposition (Diefenbaker
of the Conservative Party), reported to the Pearson Liberal Government, recommending a national
Medicare program. In 1966, the Federal Government created The Health Resource Fund to help
build hospitals and purchase equipment. In 1967, the federal Minister of Health, Allan McEachen
(Liberal), succeeded in passing The Medical Care Act. By January 1971, all provinces had “Medicare”
despite a bitter specialists’ strike in Quebec in 1970.
The transfer of funds set-up by the Canada Health and Social Transfer (1996) replaced the old
50-50 formula and the provinces began to hold an increasingly large share of the costs of health
care. However, the five fundamental conditions for health services across the country, as set up by
the Canada Health Act (1984), were maintained. The five principles of the Canada Health Act are the
cornerstone of the Canadian health care system and have iconic status for Canadians. This legisla-
tion, passed unanimously by Parliament in 1984, affirmed the Federal Government's commitment
to a universal, accessible, comprehensive, portable and publicly administered health insurance system.
The administration of the health care insurance plan of a province or territory must be carried out
on a non-profit basis by a public authority. All medically necessary services provided by hospitals
and doctors must be insured. All insured persons in the province or territory are entitled to public
health insurance coverage on uniform terms and conditions. Coverage for insured services must be
maintained when an insured person moves or travels within Canada or travels outside the country.
Reasonable access by insured persons to medically necessary hospital and physician services must
be unimpeded by financial or other barriers. The Canada Health Act contains provisions that ban
extra-billing and user-charges, which means there is to be no extra-billing by medical practitioners
or dentists for insured health services under the terms of the health care insurance plan of the prov-
4 1. THE HEALTH CARE SYSTEM IN NORTH AMERICA (CANADA AND U.S.)
ince or territory; this also applies to user-charges for insured health services by hospitals or other
providers under the terms of the health care insurance plan of the province or territory.
Although much of the Medicare costs are covered by public funds, hospital food, laundry and
laboratory tests are frequently done in the private sector, therefore Canada currently has a mixed
model rather than a social insurance one. The taxation base covers basic health care expenditures,
which includes general taxation on personal income, on corporations, and on the sales of some
goods and services. Charitable contributions cover some of the costs of equipment. The provincial
government allocates a budget for hospital expenses related to continuing care, public health, men-
tal health and rehabilitation services. A global budget is set for physicians’ fees which are negotiated
with the provincial medical association; the latter then allocates the funds by specialty.
Since 1980, the median for Western nations’ health care expenditures as a percentage of the
GDP was around 7-8%. In 1999, the median was 7.9%. That year, Canada was the fourth highest
spender at 9.3%, equal with France. Below this benchmark were U.K., Spain, Finland and Japan.
Countries with expenses higher than the median were Canada, France, Germany, Switzerland, and
the U.S.. In 2011, Canada was at 11.2% and the U.S. was at 17.7% of GDP; the U.K. was at 9.4
and France at 11.6 (OECD, 2013_health care expenditures).
In 2009, Canada spent 8% from public funds and 3.3% from private ones; the U.S. spent 8.3%
from public funds and 9.1% from private funds. The last ranking carried-out by the WHO on the
quality of health care was done for the year 2000: Canada ranked 30th and the U.S. 37th (WHO).
For the year 2008, life expectancy of women in Canada was 83.1 years, men 78.3, and mortality
under the age of 5 was 5 per 1000. In the same year in the U.S., life expectancy for women was 80.6
years and for men 76, and child mortality was 8 per 1000. There are many other interesting statistics
for all OECD countries on the website of that organization (OECD, 2013_life expectancy).

1.2 UNITED STATES

Defining the American health system, Holahan et al. (2007) wrote:
In the U.S., direct government funding of health care is centered on Medicare, Medic-
aid, and the State Children’s Health Insurance Program (SCHIP), which cover eligible
senior citizens (65 years or over), the very poor, disabled persons, and children. The fed-
eral government also runs the Veterans’ Administration that provides care to retired or
disabled veterans, their families, and survivors through medical centers and clinics. The
U.S. government also runs the military health system. One study estimates that about
25% of the uninsured in the U.S. are eligible for these programs but many people are not
enrolled; however, extending coverage to all who are eligible remains a fiscal and political
challenge (Holahan et al., 2007).
1.3. COVERAGE AND ACCESS 5
For everyone else, health insurance must be privately paid. In 2008, around 58% of U.S.
residents had access to health care insurance through their employer (DeNavas-Walt et al., 2009)
People whose employers do not offer health insurance and those who are self-employed or unem-
ployed must purchase insurance on their own. People who enroll in Medicare need to buy Part A
services and they can also buy Part B at additional cost. What Medicare does not cover for those
enrolled in these plans are: Long-term care, routine dental or eye care, dentures, cosmetic surgery,
acupuncture, hearing aids and exams for fitting them, and routine foot care. These can be covered
by other insurance programs if provided by the employer or if purchased by the person (Medicare.
gov, n.d.). The abstract from a paper by Ficella (2011) summarizes the state of health in the U.S.
in that year:
The United States has made little progress during the past decade in addressing health
care disparities. Recent health care reforms offer a historic opportunity to create a more
equitable health care system. Key elements of health care reform relevant to promoting
equity include access, support for primary care, enhanced health information technol-
ogy, new payment models, a national quality strategy informed by research, and federal
requirements for health care disparity monitoring. With effective implementation, im-
proved alignment of resources with patient needs, and most importantly, revitalization of
primary care, these reforms could measurably improve equity (Fiscella, 2011).
Similar to the situation in Canada, the U.S. government is highly involved in health care
through regulation and legislation. In 1973, the Health Maintenance Organization Act provided
grants and loans to subsidize Health Maintenance Organizations (HMOs); the Act contained
incentives to stimulate their popularity. HMOs had been declining before the passing of this law;
but by 2002, there were 500 such plans enrolling 76 million people (Medical News Today, 2004).

1.3 COVERAGE AND ACCESS

In both Canada and the U.S., access to health care can be a problem. For many Canadians, the
first point of contact for medical care is a doctor, so not having access to a regular medical doctor
is associated with fewer visits to general practitioners or specialists, who can play a role in the early
screening and treatment of medical conditions. In 2012, 14.9% of Canadians aged 12 and older,
roughly 4.4 million people, reported not having a regular medical doctor. More males than females
reported not having a regular medical doctor. However, when people cannot find a family doctor
to enroll with, Canadian Citizens are still covered by the national health care system, so they can
usually find a walk-in clinic and see the doctor on call (Statistics Canada, 2012).
In the U.S., a recent report by the Commonwealth Fund stated that the Affordable Care Act,
which will go into effect in January 2014, will provide new insurance options for people without
health insurance, enabling 14 million uninsured people to gain coverage in that year, and 27 million
6 1. THE HEALTH CARE SYSTEM IN NORTH AMERICA (CANADA AND U.S.)
by 2021. The Commonwealth Fund Biennial Health Insurance Survey of 2012 found that half of
adults (46%) aged 19–64 (estimated as 84 million people) did not have insurance for the full year
or were underinsured and unprotected from high out-of-pocket costs; and 2/5 (41%) adults (75
million people) reported having problems paying their medical bills or were paying off medical
debt; while more than 2/5 (43%) or 80 million people reported problems getting needed health
care (Commonwealth Fund, 2013).

1.4 HEALTH CARE FACILITIES

The biomedical engineer and biomedical technician, to interface effectively with health care facil-
ities (hospitals, clinics, etc.), should understand the structure of these organizations and the types
of professionals with whom they are likely to interact. There are differences between teaching
hospitals and non-teaching ones. The former are affiliated with a Medical Faculty in a University
or with some of its medical programs and have a research role in addition to its clinical responsi-
bilities. In Canada, non-teaching hospitals are community hospitals that do not have an academic
tie. In the U.S., non-teaching hospitals are predominantly for-profit private institutions. In earlier
studies, it was shown that teaching hospitals had a larger inventory of equipment and possibly
more sophisticated and acute levels of care than community hospitals; their clinical engineering
departments would have a larger budget per value of inventory than non-teaching hospitals (Frize,
1990b). Today, this is still the case in Canada, but not necessarily the case in the U.S.; see Wang et
al. (2008) for more details.
Other factors that affect the role of a hospital and the size of its equipment inventory are:
location (rural or urban), the acuity of patients treated, and the number of beds. Hospitals with ter-
tiary services have the most acute beds (intensive care, cardiac care, etc.). Some medical specialties
that may be found in tertiary level care hospitals are: cardiac surgery, neurosurgery, neonatal and
pediatric intensive care, and other specialties that require the highest level of care. Hospitals with
secondary-level care would have some operating rooms for less complicated surgeries. They would
have medical imaging facilities and may offer dialysis and other medical treatments. Primary-level
care hospitals would likely have out-patient clinics, and either short-term or longer-term patient
care for chronic diseases; some would have some type of emergency services.
The health care professionals with whom clinical engineers and biomedical technicians in-
teract most frequently are nurses. Nursing personnel are usually the people operating many of the
medical equipment in the hospital. Examples are cardiac monitors, infusion pumps and controllers,
defibrillators, pacemakers, incubators and many other types of devices. Clinical Engineering De-
partments (CEDs) also interact with respiratory and medical imaging technologists, audiologists,
physiotherapists, and anyone else using medical devices in the health care environment. Physicians
are important partners; they are most frequently in a position to request new equipment and to
1. REFERENCES 7
make choices on what they would like to have for making a diagnosis, a treatment, or to monitor
patients.
The next chapter presents various sensor technologies to measure physiological variables in
the human body in order to make a diagnosis, treatment, or monitor a patient’s condition.

REFERENCES
Commonwealth Fund (2012). Report available at: http://www.commonwealthfund.org/Publica-
tions/Fund-Reports/2013/Apr/Insuring-the-Future.aspx; last accessed September 2013.
DeNavas-Walt, C, Proctor, BD, Smith, JC ( 2009). “Income, Poverty, and Health Insurance Cov-
erage in the United States: 2008: Table 59." Available at: http://www.census.gov/prod/
2009pubs/p60-236.pdf; last accessed July 2013.
Fiscella, K (2011). “Health Care Reform and Equity: Promise, Pitfalls, and Prescriptions.” Ann.
Family Med., Jan, 9(1): 78–84. DOI: 10.1370/afm.1213.
Frize, M (1990b). “Results of an International Survey of Clinical Engineering Departments. Part
II: Budgets, Staffing, Resources and Financial Strategies.” Med. Biol. Eng. Comput., 28:
160-165. DOI: 10.1007/BF02441772.
Health Canada (2010). “Health Care System.” Available at: http://hc-sc.gc.ca/hcs-sss/medi-assur/
index-eng.php; last accessed July 2013.
Holahan, J, Cook, A, Dubay, L (2007). “ORG1 Characteristics of the Uninsured: Who is Eligible
for Public Coverage and Who Needs Help Affording Coverage?” Available at: http://
kaiserfamilyfoundation.files.wordpress.com/2013/01/7613.pdf; last accessed July 2013.
Medical News Today (2004). “Health Care Expenditures in the USA.” Available at: http://www.
medicalnewstoday.com/releases/6225.php; last accessed July 2013.
Medicare.gov (n.d.). “What Medicare Covers.” Available at: http://www.medicare.gov/what-medi-
care-covers/; last accessed July 2013.
OECD (Organization for Economic Co-operation and Development), 2013_health care expendi-
tures, available at: http://www.oecd-ilibrary.org/social-issues-migration-health/total-ex-
penditure-on-health_20758480-table1; last accessed September 2013.
OECD, 2013_Life expectancy, available at: http://www.oecd-ilibrary.org/social-issues-migra-
tion-health/life-expectancy-at-birth-total-population_20758480-table8; last accessed
September 2013.
Statistics Canada (2012). Available at: http://www.statcan.gc.ca/pub/82-625-x/2013001/arti-
cle/11832-eng.htm; last accessed September 2013.
8 1. THE HEALTH CARE SYSTEM IN NORTH AMERICA (CANADA AND U.S.)
Wang, B, Eliason, RW, Richards, SM, Hertzler, LW, Koenigshof, S (2008). “Clinical Engineering
Benchmarking: An Analysis of American Acute Care Hospitals.” J. Clin. Eng., 33(1):
24-27. DOI: 10.1097/01.JCE.0000305843.32684.52.
World Health Organization (2000). “The World Health Report 2000 - Health Systems: Improv-
ing Performance.” Available at: http://www.who.int/whr/2000/en/whr00_en.pdf; last
accessed July 2013.

Measuring Physiological Variables in

Humans
There is a wide variety of technologies to measure human physiological variables and this is the
subject of several books. This chapter provides an overview of common measurements performed on
the human body and describes the types of sensors used to measure these physical quantities such
as temperature, cardiac activity, blood pressure, chemistry values in the blood and urine, enzymes,
and proteins.
Sensors are devices that provide an electrical signal when receiving a stimulus which could
be a pressure, movement, chemical reaction, among others. A transducer is defined as a device that
converts one physical quantity into another. “Sensors” and “transducers” are frequently used inter-
changeably. In this chapter, the word sensor is used for any device that allows the measurement of
a physical quantity in humans. Testing in humans is a very important part of the medical act to
establish a diagnosis for a patient’s condition. Testing also allows caregivers to assess whether the
treatment plan is improving the patient’s condition and by how much. The major trend in biomed-
ical sensor development is to design non-invasive testing mechanisms, which means they do not
pierce the body at any point. However, there are still invasive techniques used regularly in medicine,
as they may be more accurate; also, they are used where a non-invasive technique does not exist.

2.1 COMMON MEASUREMENTS OF PHYSIOLOGICAL

VARIABLES
Readers should familiarize themselves with the physiology of the human body prior to learning
about sensor technologies.

2.1.1 THE HEART

The heart has four chambers: two atria and two ventricles. There are two cycles in the heart: systole
is the pumping phase in which the ventricles contract; and diastole is the resting phase and the
filling of the atria. There are a number of measurements that can be done to assess the health of the
heart and to identify diseased states. The electrocardiogram (ECG) is the electrical signal which
can be captured with a set of electrodes placed on the chest, arms, and legs. Electrodes must make
a good contact with the skin; the best ones are made of Ag-Ag-Cl (silver-silver-chloride) and con-
tain an electrolyte as gel. Cardiologists are trained to read the signal recorded on paper to detect
10 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
if the signal is normal or whether it contains abnormalities or irregular beats (also called arrhyth-
mias); see Figure 2.1 for an example of the ECG lead connections and the signals they produce
(Wikipedia_Cardiology). When monitoring the ECG of a patient for several days in a cardiac care
center, the usual electrode configuration is lead-II, which consists of three electrodes. However, a
12-lead configuration is used when recording the ECG on a printer called an electrocardiograph,
for diagnostic purposes. In addition to these measurements, the cardiologist can require a stress test
that consists of a 12-lead ECG collected while the patient walks on a treadmill. This provides infor-
mation when the patient is undergoing physical effort. Sometimes the physician orders a thallium
stress test; in this case, the patient is injected with an isotope, then undergoes a gamma camera test
(imaging of the heart), followed by a stress test, then a gamma camera imaging again. The gamma
camera imaging shows the cardiologist if there are some areas of the heart that have been damaged,
and the stress test may indicate whether some of the vessels near the heart have a blockage.
The ECG signals are quite small, usually of the order of 1 millivolt, so they must be am-
plified at least 1,000 times to be seen by instruments such as the cardiac monitor (similar to an
oscilloscope) or on the electrocardiograph (printer). Another tool used by cardiologists is the Holter
Monitor which records the ECG for a longer period (24 or 48 hours); the signal is played back
in a rapid mode to assess the number and types of arrhythmias present during the period tested.
Common conditions that can be diagnosed with the electrical signal of the heart are: aneu-
rysm, angina, angina pectoris, arrhythmias, atrial fibrillation, arteriosclerosis, bradycardia, conges-
tive heart failure, a heart attack, tachycardia, and ventricular fibrillation.
2.1. COMMON MEASUREMENTS OF PHYSIOLOGICAL VARIABLES 11

Figure 2.1: ECG lead connections and the respective signals they produce. (Source: http://www.ivline.
info/2010/05/quick-guide-to-ecg.html)

Signal Conditioning for the ECG

In addition to the need for amplification, other important features are: the need to eliminate 50 or
60 Hz interference which can cause a wandering baseline; muscle tremor can also be a problem, so
patients are required to lie down in a relaxed state for this test. There are filters in the amplifier to
help reduce these problems.

2.1.2 NON-INVASIVE BLOOD PRESSURE MEASUREMENTS (NIBP)

The simplest way to measure arterial blood pressure is using a stethoscope and a cuff that can be
inflated and deflated; this is called the Korotkoff sounds method. The cuff is inflated to a level
above the systolic pressure and then the cuff is deflated slowly. Through the stethoscope, the nurse
or doctor listens to the Korotkoff sounds; tapping, repetitive sounds for at least two consecutive
beats occur at the systolic pressure point; the second sounds are the murmurs heard for most of
the area between the systolic and diastolic pressures; the third sound is a loud, crisp tapping sound;
the fourth sound, at pressures within 10 mmHg above the diastolic blood pressure, is described as
"thumping" and "muting"; the fifth Korotkoff sound is silence as the cuff pressure drops below the
diastolic blood pressure. The disappearance of sound is considered to be at the diastolic blood pres-
12 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
sure point, which is 2 mmHg below the last sound heard. Figure 2.2 is a description of the signal
shape and measurement (Wikipedia_Korotkoff_sounds).
Today, several automatic instruments have been designed to imitate this method and provide
a numeric value of the systolic and diastolic pressures. However, the accuracy of these devices varies
greatly. The value of blood pressure varies during various parts of the day or night and also according
to levels of stress experienced. These devices are useful to keep track of the trend of a person’s blood
pressure and as a warning when abnormal values are found.

Figure 2.2: Korotkoff sounds to measure arterial blood pressure. (Source: adapted in English from:
http://en.wikipedia.org/wiki/Korotkov_sounds)

2.1.3 INVASIVE BLOOD PRESSURE

For a more accurate measurement, especially when patients are in a critical or intensive care unit,
invasive blood pressure measurement techniques are frequently used, especially for the long-term
monitoring of cardiovascular instability. This allows to avoid the frequent use of an inflated cuff,
thus preventing damage to the tissue of the arm; the invasive method is also reputed to be far more
2.1. COMMON MEASUREMENTS OF PHYSIOLOGICAL VARIABLES 13
accurate for blood pressure measurement. A cannula made of Teflon or polyurethane is inserted
into an artery, a 20G cannula for adults, but smaller (22G and 25G for children and neonates).
Preferably, the radial or dorsalis pedis artery is used in adults to measure the arterial systolic and
diastolic pressure (Ward and Langton, 2007).
For measuring central venous pressure, the catheter is inserted into a vein; this is similar to
the pressure in the atrium of the heart. In some cases, the measurements are done directly into the
chambers of the heart using a Swan-Ganz catheter to measure the right or left ventricular pressure
and the pulmonary artery pressure; the pulmonary capillary wedge pressure is done by inflating the
end of the catheter for a second or so. The catheter is connected to a three-way stop-cock and to a
pressure transducer (sensor). A heparinized saline solution is connected to the stop-cock in order to
flush the catheter periodically, which helps to prevent blood clotting at the tip of the catheter. An-
other of the outputs of the stop-cock is used to draw blood for blood gas testing, which is another
important measurement for critically ill patients. The transducer is described in the physical sen-
sors section further below. The saline bag is pressurized to about 200 mmHg to prevent the blood
from backing up. The sensor must be placed at the level of the midline of the body measured at
the chest area in order to produce accurate measurements. Invasive pressure measurements are only
performed in a special unit (an intensive care or in a catheterization laboratory). See Figure 2.3.

Figure 2.3: Blood pressure transducer and catheter. (Source: adapted from http://www.aic.cuhk.edu.
hk/web8/haemodynamic%20monitoring%20intro.htm)
14 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
2.1.4 DEFIBRILLATION
When a person’s heart stops or goes into fibrillation, it is desirable to perform cardio-pulmonary
resuscitation and apply defibrillation through two paddles placed across the chest. Ventricular
fibrillation is a condition in which there is uncoordinated contraction of the ventricles of the heart
which quiver rather than contract, and so the pumping of blood stops. The paddles are either metal
with gel applied for a good contact with the skin or they are disposable gel pads. The device provides
an electric shock of short duration (around 5 ms) at a high voltage and current (typically up to
3000 volts at full power). This can help to bring the heart back into sinus rhythm (normal rythm).
Automated external defibrillators (AEDs) are available in many public spaces such as airports,
train stations, airplanes, ships, among others; they claim to be easy to use, especially if people have
followed a cardiopulmonary resuscitation course (CPR) that includes training on how to use these
defibrillators. They can save people’s lives when used quickly on persons who are having a heart
arrest. When the paddles are placed on the person, the device can identify whether a shock should
be administered or not by identifying if the person’s heart is in fibrillation or tachycardia (extra fast
heart rate that can easily go into fibrillation). It is a simple process to charge the paddles with the
high voltage and discharge them into the person. There are also small defibrillators implanted into
the chest that discharge a voltage to the heart when the patient experiences a ventricular fibrillation
or tachycardia.

2.1.5 PACING THE HEART

Figure 2.4 shows the conductive pathways in the heart (Wikipedia_Electrical_Conduction_Heart).
Heart block is a problem with the heart's electrical system, which controls the rate and rhythm
of heartbeats. With each heartbeat, an electrical signal spreads across the heart from the upper to
the lower chambers, which causes the heart to contract and pump blood. Heart block occurs if the
electrical signal is slowed or disrupted as it moves through the heart. The three types of heart block
are: first degree, second degree, and third degree. First degree is the least severe, and third degree
is the most severe. This is true for both congenital and acquired heart block. Second-degree Type I
means the heart has a slower rate, but this is not sufficiently low to warrant the use of a pacemaker.
However, second-degree Type II is more severe and could degenerate into a third degree heart
block, so a cardiologist may decide that a pacemaker is desirable at that stage (NIH, 2012).
2.1. COMMON MEASUREMENTS OF PHYSIOLOGICAL VARIABLES 15

Figure 2.4: Pacing the heart. (Source: http://en.wikipedia.org/wiki/File:Conductionsystemofthe-

heartwithouttheHeart.png)

Pacemakers can be used externally in an emergency situation. However, when this device is
prescribed for permanent use, it is implanted into the chest. The pacemaker produces a signal that
replaces the signal of the sino-atrial (SA) node when the latter does not send signals for the heart
to pump blood (complete block) or only functions for part of the time (partial block).
There are several types of pacemakers. The single-chamber pacemaker has one pacing lead
attached to a chamber of the heart, either the atrium or the ventricle. With the dual-chamber
pacemaker, one lead paces the atrium and another paces the ventricle. This type closely resembles
the natural pacing of the heart by coordinating the function of both the atria and the ventricles.
The rate-responsive pacemaker is the most complex and expensive. Its sensors detect changes in the
patient's physical activity and automatically adjust the pacing rate according to the body's needs. An
image of a pacemaker and leads is shown in Figure 2.5.
16 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS

Figure 2.5: Typical pacemaker and leads. (Source: http://en.wikipedia.org/wiki/File:St_Jude_Medi-

cal_pacemaker_with_ruler.jpg)

2.1.6 THE BRAIN

The neurons in the brain emit signals, which can be recorded on the scalp; the electrical signal is
called the electroencephalogram (EEG). It is used to diagnose epilepsy, tumors, stroke, coma, or
brain death, among others. This signal is very small, of the order of 10 microvolts. The most com-
mon approach is to use small needle electrodes which are pinned on the scalp placed at specific
positions. The international configuration is the most commonly used; it is shown in Figure 2.6. The
10-20 system refers to the distance between adjacent electrodes which are either 10% or 20% of the
total front-back or right-left distance of the skull. Each site has a letter to identify the lobe and a
number to identify the hemisphere location: F, T, C, P and O correspond to frontal, temporal, cen-
tral, parietal, and occipital lobe, respectively. There is no central lobe; the "C" letter is only used for
identification purposes. A "z" (zero) refers to an electrode placed on the midline. Even numbers (2,
4, 6, 8) refer to electrode positions on the right hemisphere, whereas odd numbers (1, 3, 5, 7) refer
to those on the left hemisphere. Two anatomical landmarks are the points between the forehead
and the nose and the lowest point of the skull from the back of the head, normally indicated by a
prominent bump. (Wikipedia_electrodes_international system 2013)
2.1. COMMON MEASUREMENTS OF PHYSIOLOGICAL VARIABLES 17
Researchers in the 1930's and 1940's identified several different types of brain waves: delta
waves (below 4 Hz) occur during sleep; theta waves (4-7 Hz) are also associated with sleep, deep
relaxation and visualization; alpha waves (8-13 Hz) occur when we are relaxed and calm or during
meditation; and beta waves (13-38 Hz) occur when we are actively thinking, problem-solving, or
doing mathematical calculations. Today, more types have been added: the sensory motor rhythm
(SMR, around 14 Hz) was originally discovered to prevent seizure activity in cats. SMR activity
seems to link the brain and body functions. Gamma brain waves (39-100 Hz) are involved in higher
mental activity and consolidation of information. (Brain and Health, n.d.)

Figure 2.6: International electrode configuration for EEG. (Source: http://en.wikipedia.org/wiki/

File:21_electrodes_of_International_10-20_system_for_EEG.svg)

2.1.7 ELECTROMYOGRAPHY (EMG)

Electromyography (EMG) is a test to assess the health of the muscles and of the nerves that control
the muscles. A needle electrode is inserted through the skin into a muscle and the electrical activity
is displayed on a monitor. Frequently, the electrical discharges are also heard with a speaker. The
presence, size, and shape of the waveform, and the action potential produced on the monitor pro-
vide information about the ability of the muscle to respond when the nerves are stimulated. Nerve
conduction velocity (NCV) is a test of the speed of conduction of impulses through a nerve; in
18 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
this test, the nerve is stimulated, usually with surface electrodes placed on the skin over the nerve
at various locations. One electrode stimulates the nerve with a very mild electrical impulse. The
resulting electrical activity is recorded with the other electrodes. The distance between electrodes
and the time it takes for electrical impulses to travel between electrodes are used to calculate the
nerve conduction velocity.
The amplitude of this signal can vary between 20 and 2000 microvolts; the frequency is 6-30
per second. Pathologies can cause slower nerve conduction, less synchronization (scatter), lower
amplitudes, and a modified shape of the signal. EMG signals have also been useful for many years
to control artificial arms and hands.

2.1.8 RESPIRATION
There are various methods to measure the rate of respiration, but a common one, which is non-in-
vasive and can be used while the person is moving (ambulatory), uses RIP bands (respiratory induc-
tive plethysmography). Two elastic bands in which coils are embedded are placed, one around the
chest and the other around the abdomen. A small alternating current is applied to the coils, creating
a small magnetic field normal to the coil. Each breath causes a change in the cross-sectional area of
the body, which changes the shape of the magnetic field generated by the belt, inducing an opposing
current which can be measured, see Figure 2.7 (Wikipedia_inductance_plethysmography).

Figure 2.7: Rip bands to measure respiration cycle. (Source: http://en.wikipedia.org/wiki/Respira-

tory_inductance_plethysmography)
2.2. TRANSDUCERS AND SENSORS 19
2.1.9 MEASUREMENT OF TEMPERATURE
Several sensors exist to measure temperature. The oldest method is the thermometer in which red-
dyed alcohol is displaced in a glass tube that is calibrated to the temperature of humans. Electronic
thermometers determine the temperature by measuring the change in electrical resistance of a
metal wire or of a thermistor that is composed of a semiconducting material. The wire or thermis-
tor is usually enclosed in a slender rod, or probe. A change in temperature causes a change in the
resistance of the thermistor. The temperature is indicated on a meter or as a digital display.
An important use of thermistors is with an infant incubator. A sensor is placed on the in-
fant’s abdomen to measure the body temperature; this information is fed back to the incubator
temperature control to maintain a constant ambient environment for premature babies who have
an immature temperature regulation system. The thermistor chosen for this application is one that
is linear for the small range of temperature needed to keep the infant warm; see Figure 2.8.

Figure 2.8: Incubator for premature infants. (Source: http://www.sciencephoto.com/im-

age/290781/530wm/M8200156-Baby_in_incubator,_father_looking_on.-SPL.jpg)
20 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
2.2 TRANSDUCERS AND SENSORS
A sensor is a device that measures a physical quantity; there are many types of sensors and some
examples are provided below. A transducer transforms one physical quantity that is captured into
another form of signal, usually an electrical output. Both terms are used in the section below. Sen-
sors, like transducers, can change the quantity measured into another form, which is why the two
terms are often used interchangeably.
In physical sensors, the effect depends on the physical nature of the input stimulus; the
output is usually an electrical signal. Examples are resistance sensors, inductive sensors, capacitive
sensors, piezoelectric sensors, electromagnetic sensors, photoelectric sensors, and thermoelectric
sensors (Wang & Liu, 2011). For example, a metal resistive strain gage is frequently used to measure
invasive blood pressure. As blood exerts a pressure on a strain gage, it causes the elastic material
to deform, which in turn causes a change in the resistance of the material of the strain gage; this
resistance change can be measured by a Wheatstone bridge; the electrical output is proportional
to the displacement of the strain gage and thus to the pressure exerted by the blood. This type of
sensor is referred to as a blood pressure transducer.
There are other types of transducers that can measure blood pressure invasively. A capacitive
transducer has a capacitance that changes with the displacement of the two plates with the move-
ment of the blood on the plates. The inductive type has a change in the inductance that is based
on the displacement of two coils by the movement of the blood. Piezoresistive materials such as
silicon can be used in the same manner as a strain gage; they deform with displacement and the re-
sistance change can be measured by a Wheatstone bridge. Today, with the development of MEMS
(micro-electro-mechanical systems), pressure sensors (transducers) are very small and can be used
at the tip of a catheter. They have many applications, including the measurement of intracranial
pressure, intrauterine pressure in obstetrics, and air pressure during respiration to assess respiratory
diseases. MEMS are also used in cochlear implants (Wang & Liu, 2011).

2.2.1 CHARACTERISTICS OF PHYSICAL SENSORS

The performance of sensors can be measured by the following characteristics (Wang & Liu, 2011;
Webster, 2009).

The Transfer Function

The transfer function defines the relationship between the input quantity to be measured and the
electrical signal produced at the output. This determines other parameters such as the sensitivity,
which is simply defined as the amount of change produced in the output signal in response to a
change in the input quantity measured. A large output signal for a small change in the input would
represent a large sensitivity.
2.2. TRANSDUCERS AND SENSORS 21
Span or Range

The span or range describes the range of input quantity that can be used with the sensor. For
example, in a thermometer for human use, the ideal range needs to be close to a normal tem-
perature, with a few degrees under and over the normal, representing the small range that can
occur in live persons. Similarly, for blood pressure measurements, the range to measure arterial
pressure (50–180 mm Hg) is larger than the measurement of venous pressure whose range is
typically less than 20 mm Hg.

Hysteresis

The sensor output does not return to its original output value when the input quantity goes up and
down or to a value of zero. Hysteresis is like memory and represents the size of the error in terms
of the measured quantity. Sensors need to be calibrated regularly in order to function properly.
For invasive blood pressure sensors, it is recommended to re-calibrate every time there is a shift of
personnel (at 8 or 12 h) and more frequently if a problem in the output value is suspected. More
frequent calibration is not justified because when the stop-cock is opened to the atmosphere for
calibration infection can be a risk.

Non-Linearity

Non-lineraity refers to the maximum deviation from a linear transfer function. The error compares
the actual transfer function to the best straight line.

Noise

All sensors produce some noise in addition to a signal. Normally, this is “white noise” which is
composed of a signal with equal amplitude for a wide range of frequency.

Resolution

Resolution is defined as the smallest detectable input quantity change.

Bandwidth

All sensors have a finite response time to an instantaneous change in the input signal. Moreover,
many sensors have decay times, which would represent the time after a step change in the input
signal for the sensor output to decay to its original value. The reciprocal of these times corresponds
to the upper and lower cutoff frequencies, respectively. The bandwidth of a sensor is the frequency
range between these two frequencies
22 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
2.2.2 CHEMICAL SENSORS

Propertied by Properties

This type of sensor responds to a chemical reaction and produces an electrical signal proportional to
the concentration of the biological analytes; the analyte can be one type or a multitude of types to
be analyzed. The earliest chemical sensor was developed by Cremer in 1906; glass thin film responds
to hydrogen ions in a solution, so Cremer developed a glass electrode to measure the pH. It is after
the 1960s that chemical sensor development expanded rapidly.
Chemical sensors have been classified into three categories: ion sensors, gas sensors, and hu-
midity sensors. Ion sensors are usually small, with a fast response, wide range, with high selectivity
and sensitivity, and are not expensive. The principle behind an ion-selective sensor is as follows. The
sensor has a membrane that separates the sample solution and a reference solution. Assuming that
the membrane is only selective to one type of ions, then the diffusion occurring causes a potential to
accumulate on the reference electrode (assume it is positive), then a negative potential accumulates
on the ion-sensitive electrode. The difference of potential is proportional to the concentration of the
specific ion in the sample solution (Wang & Liu, 2011). There are millions of chemical substances
in the world and many types of sensors have been created to measure these. Some applications are
in environmental, agricultural, weather, and health care measurements. In medicine, they include
measuring the pH, sodium, and potassium in the blood. An example in health care is the measure-
ment of glucose in the blood, which is important for diabetic patients; another is the measurement
of urea in urine to assess the condition of the kidneys. Recent developments are the e-Nose, the
e-Tongue, and the µTAS (micro total analysis system).

Electronic Nose

The electronic nose is a device designed to detect odors and flavors. There are possible applications
in the field of health care such as the detection of bacteria; this is currently applied to recogniz-
ing the smell of the MRSA (Methicillin-resistant Staphylococcus Aureus), a highly resistant and
dangerous bacteria. If such a system is placed in a hospital’s ventilation system, it can detect and
therefore prevent the contamination of other patients near those who are affected. Equipment
could also be safer from being exposed to highly contagious pathogens. The e-nose can also detect
lung cancer and certain other medical conditions by detecting the volatile organic compounds that
are present with the medical condition. Nasal implants could warn of the presence of natural gas,
for people who have a weak or no sense of smell (Wikipedia_electronic_nose).
2.2. TRANSDUCERS AND SENSORS 23
Electronic Tongue

The electronic tongue is a device that can compare and measure different tastes. Current devices
use seven sensors, each of which is capable of detecting dissolved organic and inorganic compounds
that are normally detected by the human receptors. In fact, it is claimed that most of the detection
thresholds of these sensors are similar or better than those of human receptors. In the biological
mechanism, taste signals are translated into electric signals. The e-tongue sensors function in a
similar way; they generate electric signals as potentiometric variations. Taste quality perception and
recognition is based on the recognition of activated sensory nerve patterns by the brain and on the
taste fingerprint of the product. This step is achieved by the e-tongue’s statistical software which
interprets the sensor data into taste patterns (Wikipedia_electronic_tongue). Some of the appli-
cations are: analyzing flavor aging in beverages; quantify bitterness or “spice level” of drinks or of
dissolved compounds; quantify the taste masking efficiency of formulations such as tablets, syrups,
powders, capsules, lozenges; and analyzing medicine stability in terms of taste.

Micro-Total Analysis System (µTAS)

The Micro-Total Analysis System (µTAS) is a laboratory on a chip (LOC). Because of the signif-
icant miniaturization, many tests can be conducted with a very small device built on a chip. These
small devices provide low cost fast results of analyses at the point-of-care. Today, the devices can
integrate several laboratory functions in a chip size of a few square millimeters to a few square
centimeters in size. They need a small volume of the fluid to be tested, typically less than a pico
liter (that is, 10-9). The devices can range from simple channels to more complex gear wheels and
levers, valves and pumps, all on a chip. They can be detectors like electrodes, fiber optics, and sen-
sors; combining these can produce small complex instruments. Applications in the 1990s were in
genomics, such as capillary electrophoresis and DNA microarrays. Because of their low cost, they
may be appropriate tools for developing countries.
The most common material used is silicon and most fabrication processes use photolithogra-
phy. New processes have been developed such as glass, ceramics and metal etching, deposition and
bonding, and polydimethylsiloxane (PDMS) processing (Reyes et al., 2002). Some of the advan-
tages of LOC are: low fluid volume, faster analysis, compactness of systems, and lower fabrication
cost. Disadvantages are: this is a novel technology and therefore not yet fully developed; physical
and chemical effects on a small scale may become more important and thus make processes more
complex to deal with than conventional instruments; detection principles may not scale down well,
leading to low signal-to-noise ratios; and although precision is high in micro fabrication, the geo-
metric accuracy may be poor compared to precision engineering (Wikipedia_ MTAS).
24 2. MEASURING PHYSIOLOGICAL VARIABLES IN HUMANS
2.3 GAS SENSORS
There are several types of gas sensors such as electrochemical, semiconductor, optical, solid elec-
trolyte; most have industrial and domestic applications. For example, electrochemical gas sensors
are used to detect low levels of toxic gases and oxygen in domestic and industrial environments.
Important non-invasive sensors for medical applications are the transcutaneous partial pressure of
oxygen in the blood (tc-pO2) and the partial pressure of carbon dioxide in the blood (tc-pCO2);
pO2 and pCO2 are vital measures for babies on artificial ventilation; these transcutaneous mea-
surements enable the medical team to reduce the amount of blood taken from the infant for blood
gas analysis during the premature infant’s stay in the neonatal intensive care.
It is possible to monitor continuously and non-invasively the pO2 of an infant using a heated
Clark electrode on the skin. Changes in oxygen levels can cause significant complications in these
infants such as retinopathy of prematurity (ROP) or broncho-pulmonary dysplasia (BPD). It is
known that there are variations between transcutaneous values and those obtained by blood gas
analysis using the infant’s blood. But the monitors present a trend on a continuous basis, which
is helpful for long-term monitoring. However, these values should be compared with the blood
gas values at regular intervals. The other issue is that, for optimum operation, the Clark electrode
must be heated to around 44° C. That can cause burns if the electrode is not moved every three to
four hours. Considering that there may be two electrodes (O2 and CO2) on a very tiny body, this
is not an easy approach, but it does help to limit the amount of blood loss for the infant. For the
CO2 electrode, a study compared transcutaneous CO2 and end-tidal CO2 (ETCO2) to arterial
measurement of CO2 and found that the tc-CO2 method was more accurate than the ETCO2
approach in ventilated pediatric patients who were four years old or more. The article mentions
that the accuracy of tc-CO2 has been demonstrated in neonates because they have a thin skin with
fewer diffusion barriers to capillary gases (Berkenbosch et al., 2001).
The next chapter discusses the equipment management process in health care institutions.

REFERENCES
Berkenbosch, J et al. (2001). “Noninvasive monitoring of carbon dioxide during mechanical venti-
lation in older children: end-tidal versus transcutaneous techniques.” Anesth Anal, June,
92(6): 1427-31.
IVLINE (2000). “A quick guide to ECG.” Available at: http://www.ivline.info/2010/05/quick-
guide-to-ecg.html; last accessed July 2013.
NIH (2012). “Types of heart block.” Available at: http://www.nhlbi.nih.gov/health/health-topics/
topics/hb/types.html; last accessed July 2013.
2. REFERENCES 25
Reyes, DR, Iossifidis, D, Auroux, P-A, Manz, A (2002). “Micro Total Analysis System. Introduc-
tion, Theory and Technology.” Anal. Chem. 74: 2623-2636. DOI: /10.1021/ac0202435.
Wang, P. & Liu, Q (2011). “Biomedical Sensors and Measurement.” In: s.l.:Zhejiang University
Press, Hangzhou and Springer-Verlag, Berlin, Heidelberg: 51, 62, 119-121.
Ward, M, Langton, JA (2007). “Blood Pressure Measurement.” Cont. Ed. Anaesth. Crit. Care Pain.
7(4):122-126. DOI:10.1093/bjaceaccp/mkm022.
Webster, JG, Ed. (2009). Medical Instrumentation: Application and Design. Wiley, 4th Edition.
Wikipedia, “Electrical_Conduction_Heart." Available at: http://en.wikipedia.org/wiki/Electri-
cal_conduction_system_of_the_heart; last accessed July 2013.
Wikipedia, “Electrodes international 10-20 system for EEG signals.” Available at: http://en.wiki-
pedia.org/wiki/10-20_system_%28EEG%29; last accessed July 2013.
Wikipedia, (2012). “Electronic nose.” Available at: en.wikipedia.org/wiki/Electronic_nose; last
accessed July 2013.
Wikipedia, (2012). “Electronic tongue.” Available at: http://en.wikipedia.org/wiki/Electronic_
tongue; last accessed July 2013.
Wikipedia, “Repiratory inductance plethysmography.” Available at: http://en.wikipedia.org/wiki/
Respiratory_inductance_plethysmography; last accessed July 2013.
Wikipedia, “Micro total analysis system (lab-on-a- chip)." Available at http://en.wikipedia.org/
wiki/%CE%9CTAS; last accessed July 2013.

3.1 EVOLUTION OF CLINICAL ENGINEERING IN

INDUSTRIALIZED COUNTRIES
The development of medical technologies began slowly in the first half of the 20th century. How-
ever, the 1950s and 1960s saw a major increase in the proliferation of devices applied to health care
for making diagnoses, treatments, and to monitor patients. In this period, several departments of
medical physics were created, whose main function was to calculate radiotherapy doses and to store
and dispense isotopes for treatments. Biomedical technicians were hired in some of these depart-
ments to insure the maintenance and proper functioning of electronic and mechanical devices used
in patient care.
A factor that encouraged hospitals to hire clinical engineers, at least in the U.S. and Canada,
was an article by Ralph Nader in the Ladies’ Home Journal in 1971 which claimed that there were
five thousand deaths due to electrocution in U.S. hospitals every year (Nader, 1971). Nader’s article
was based on recent discussions by biomedical professionals regarding the possibility of electrocu-
tion when patients had a catheter lodged in the heart with external leads connected to some de-
vice; a leakage current that would be in contact with the external leads could result in a ventricular
fibrillation and death if not reversed within a few minutes. Nader exaggerated the number of elec-
trocutions per year which had been cited as 1,200 by Dr. Carl Walter in his article; Nader quoted
several authoritative sources, but he hiked the number of deaths to 5,000 in his widely distributed
article (Ridgway et al., 2004, p.9).
This adverse publicity spurred hospitals to hire engineers in the U.S. and in Canada, to ensure
the electrical safety of patients. As a first priority, the clinical engineer and/or technician would test
every medical device in the hospital for electrical safety. Problems found were fixed, but sometimes
a recommendation of disposal had to be made. But it soon became clear that the majority of the
work needed involved much more than electrical safety.
In the U.S. and Canada, there were two types of professionals hired: biomedical technicians
and biomedical engineers. Some of these new professionals were given their own separate depart-
ment and various names were used to define the new type of service: Clinical Engineering Depart-
28 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
ment (CED); Medical Engineering; Biomedical Engineering. The name Medical Physics was used
for a department with physicists, although sometimes these departments also had clinical engineers
and/or biomedical technicians. In some cases, biomedical technicians and engineers reported to the
Plant Operations Department which was normally responsible for electrical, mechanical and gas
services. In the U.K., it was more common to see clinical engineers residing in a Medical Physics
Unit. In France, several clinical engineers reported directly to a Medical Director (in charge of
medical services) or to the Hospital Administrator. In the Nordic countries and in Europe, Clinical
Engineering was frequently a part of a university-based biomedical program; it provided services
to the university-affiliated hospitals and reported to the Department of Biomedical Engineering
at the university.
In the 1980s, the field of Clinical Engineering expanded rapidly in several industrialized
nations. Among the first to establish a medical equipment maintenance program in the U.S. was
the Veterans Administration (VA); the VA had a national program by 1966. At the early stage of
development of Clinical Engineering, hospitals focused on cost-effective repairs of equipment and
they mostly hired technicians (Dyro, 1988; Dyro, 2004). However, this approach did not provide
the engineering expertise which was needed in modern hospitals. When engineers were hired, at-
tention became focused on the entire life cycle management of medical equipment. The clinical en-
gineering department’s role now encompasses electrical safety, pre-purchase consultation, incoming
inspections, preventive and corrective maintenance, training of users on the safe and effective use of
equipment, and de-commissioning of equipment when obsolescent. These activities are described
in more detail further in this chapter (Frize, 1988). Clinical engineers and technicians support
various specialists such as physicians, nurses, respiratory and X-ray technologists, and several other
personnel in units where medical equipment is used.
In 1967, the American Association for the Advancement of Medical Instrumentation
(AAMI) was created with the mission to support the healthcare community in the development,
management, and use of safe and effective medical technology (AAMI, n.d.). AAMI develops
many standards on medical devices with the collaboration of industry and professionals in the field.
In 1970, AAMI began a certification process for biomedical technicians.
In 1971, The Emergency Care Research Institute (ECRI) was created. ECRI published
Health Devices, a monthly publication containing reports of defective equipment or supplies as
well as recalls for major hazards discovered with specific equipment or supply. For many decades
and even today, the ECRI Institute has provided a comparative analysis of various medical devices,
similarly to Consumer Report (ECRI, n.d.).
Another important step in the development of the discipline of Clinical Engineering was
the establishment of a certification process to assess the competence of engineers and technicians.
A few Canadian engineers and technicians including this author, received their certificate in 1973
3.1. EVOLUTION OF CLLINICAL ENGINERING 29
from the U.S. Certification Board of AAMI. However, the certification process was later made
available in Canada through the Canadian Medical and Biological Engineering Society (CMBES).
Another impetus to hire biomedical professionals arose from a guideline set in 1974-1975
by The Joint Commission (TJC), called Joint Commission on Hospital Accreditation ( JCAH) at
the time), that hospitals establish a medical equipment safety program. The accreditation is to allow
hospitals to participate in the Medicare-Medicaid programs and receive reimbursement for services
rendered. It is voluntary, not mandated by government, but if licensing is required by the states, then
it becomes mandatory. TJC visits hospitals and provides an accreditation standing to those that
meet the requirements on all aspects of health care delivery as per the TJC guidelines. In Canada, in
view of the increased use of medical devices in patient care and of the move by the Joint Commis-
sion on Accreditation of Hospitals in the United States to include aspects of medical technology
management as part of their survey of hospitals, the Canadian Council on Hospital Accreditation
asked the CMBES to prepare a brief on the proper role of clinical engineering in Canadian hos-
pitals. The brief prepared by the CMBES outlined seven basic principles associated with clinical
engineering, hospital accreditation, and the proper management of medical technology in hospitals.
These principles helped to bring some changes to the Canadian Hospital Accreditation Guide and
Questionnaires that began to include some aspects of technology management (McEwen, 1982).
In 1976, the Journal of Clinical Engineering was established. In the same year, the U.S. Con-
gress enacted the Medical Devices Amendments to the Food, Drug, and Cosmetic Act enabling
the Food and Drug Administration (FDA) to regulate the medical device industry (Dyro, 1988).
From a global perspective, the International Federation of Medical and Biological Engineer-
ing (IFMBE) set-up a Working Group for Clinical Engineering in 1979 which held its first meet-
ing in Marseilles in 1980. Original members were: A. Oberg (Sweden, Chair), C. Roberts (U.K.),
D. Kraft (GDR), Z. Katona (Hungary), and M. Frize (Canada); the mandate was to help develop
the field of clinical engineering in the 33 countries where biomedical societies were affiliated to the
IFMBE. The IFMBE, through its Working Group, published a set of criteria that represented the
minimum qualifications that clinical engineers should have to be recognized by their profession
through certification processes to be held in various countries. In 1985, the Working Group was
transformed into the Clinical Engineering Division (CED), which still exists today. Early work
consisted of organizing and co-sponsoring workshops and seminars to discuss the role and place
of clinical engineering within health care institutions. Workshops were held in London (U.K.) in
1986, Trondheim (Norway) in 1987, San Antonio (U.S.) in 1988, Patras (Greece) in 1989, Weimar
(GDR) in 1990, Kyoto ( Japan) in 1991, and Fontevrault (France) in 1992. The discussions led to a
clearer definition of the role of this profession within health care institutions and encouraged sev-
eral groups of clinical engineers in various countries to share information and expertise. This helped
the Division to develop and publish a guideline in 1991 entitled Mutual Recognition of Qualifications
30 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
for Clinical Engineers. Recent activities and reports of the Clinical Engineering Division can be
found on the website of IFMBE (ifmbe.org).
One of the early definitions of the role of a Clinical Engineering Department (CED) was
published in an article in 1988: “A CED should provide safe and effective management of tech-
nology used in patient diagnosis or therapy, within health care institutions” (Frize, 1988). In 1991,
the American College of Clinical Engineering (ACCE) was founded, an organization committed
to enhancing and supporting the profession of clinical engineering. The website of ACCE posts a
definition of the clinical engineer: "A Clinical Engineer is a professional who supports and advances
patient care by applying engineering and managerial skills to healthcare technology" (ACCE, n.d.).
Another factor that helped the new field of Clinical Engineering to develop was the rapid
proliferation of medical technologies in the 1980s. For example, in a community hospital of 540
beds in New Brunswick, Canada, the CED was responsible for the management of 320 devices in
1979, and managed more than 2000 devices by 1989, an increase of 600%. The CED at the hospi-
tal provided reports to the hospital administrators showing that in-house equipment management
delivered substantially more comprehensive services for one-third of the cost of services provided
by external companies (Frize, 1989). This type of feedback to decision-makers ensured substantial
support and recognition of the critical role played by clinical engineers and biomedical technicians
in the process of health care delivery.
A 1988 survey of CEDs in western nations, including the U.S and Canada, Sweden and
Finland, with a few respondents in the European Community, found that there were some dif-
ferences in the level of involvement of engineers and technicians in various aspects of the medical
device management functions. But overall, the field developed in a fairly similar way in most of
these geographical regions. The majority of CEDs were involved in pre-purchase consultation,
drawing specifications and requirements for device acquisitions, analysis of quotations and issued
recommendations based on criteria established with the users (physicians, nurses, and other health
care staff ). The CED performed corrective and preventive maintenance and incoming inspections
when equipment was delivered; several were involved in training users on the safe and effective use
of devices. Some of these functions were performed by biomedical technicians and others by clinical
engineers. Unfortunately, the study found that half of the CEDs responding to the survey did not
think that their work was receiving recognition from their hospital and some were not consulted
prior to equipment purchases in their institution. This study led to the development of a model
describing a desirable level of involvement in technology management, and defined the resources
needed to accomplish these tasks (Frize, 1990a,b). A longitudinal survey carried out in 1991 found
that things had not changed much in the three year span between the previous survey (1988) and
the new one (Frize, 1994).
In 1999, another survey based in large part on the Frize 1991 survey, involved six regions:
North America, Nordic countries, Western Europe, Southern Europe, Australia, Brazil, Mexico and
3.2. FUNCTION AND ACTIVITIES OF CLINCIAL ENGINEERING 31
Cuba. Results were similar to the previous surveys discussed above, except that a slightly higher
proportion of CEDs felt recognized for their work (Glouhova, et al., 2000). Later, in 2007, a new
survey of CEDs was carried-out in developing countries. Although this was also based on the 1988
Frize survey, the new survey added questions regarding equipment donations (Mullally and Frize
2008; Mullally 2008). One conclusion was that the Frize survey questionnaire was still applicable in
2007 to both developed and developing countries. The newer study enabled to assess the resources
needed by CEDs in developing countries and added new and interesting aspects about donations
of equipment to these nations.
The education level of the engineers and technicians in industrialized countries differs some-
what from those hired in developing countries. In the 1991 Frize survey, half of the departments
were staffed by engineers with a Master’s degree in biomedical engineering; just under 25% of
engineers had a doctorate; 13% had a Bachelor’s of Engineering; and 10% of the departments did
not have an engineer. For the technicians, 60% had completed a two-year program, and 23% a four-
year program. A few had done a three-year program and only 2% had one year of post-secondary
education. In developing countries, the education levels were somewhat lower; details are provided
in a later section (Frize 1994; Mullally and Frize 2008).
As mentioned previously, certification of clinical engineers (CCE) and of biomedical equip-
ment technicians (CBET) began in 1973 with AAMI, both for the U.S. and Canada. The CCE
process is currently managed by the Healthcare Technology Foundation (HTF) and the biomedical
technicians by AAMI (HTF n.d.; AAMI_certification).

3.2 FUNCTIONS AND ACTIVITIES OF CLINICAL

ENGINEERING DEPARTMENTS (CEDS)

3.2.1 IN-HOUSE MEDICAL EQUIPMENT MAINTENANCE

Most CEDs perform this role and concentrate their activities on corrective maintenance and pre-
ventive maintenance of medical equipment; this includes equipment used for monitoring patients,
treating them, or making a diagnosis; it excludes medical imaging and laboratory equipment. Some
Clinical Engineering departments have added medical imaging and laboratory equipment to their
workload, but it is likely that the most complex equipment such as the Magnetic Resonance Imag-
ing (MRI), Computer Tomography Scanner (CT-Scan), or large and complex chemistry analyzers
are covered by a service contract with an external company, either with the Original Equipment
Manufacturer (OEM) or with a third-party service agency. Some of the equipment is highly com-
plex, but others are more easily tackled, especially if some training has been provided to the biomed-
ical technicians and if they have good service manuals. The other category of equipment sometimes
managed by CEDs includes anesthetic machines and artificial ventilators and respirators.
32 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
Another service function is the incoming inspection, which is usually performed by the tech-
nicians. This consists of verifying the safety and performance of equipment delivered to the health
care facility. Incoming inspections are done for new devices just purchased or a device repaired by
an outside agency and returned to the owner. In both cases, it is critical to ensure that the device
operates within its specifications, that all accessories and parts are delivered as well as operating
and service manuals; most Canadian hospitals require that equipment be certified by the Canadian
Standards Association (CSA); in the US, National Fire Protection Association (NFPA) and the
Underwriters Laboratory (UL) have standards that can be adopted by authorities such as hospitals,
which then makes them mandatory (UL; NFPA).

3.2.2 FUNCTIONS USUALLY PERFORMED BY ENGINEERS

Equipment Acquisition

Whenever new equipment has been approved for purchase, the clinical engineer, in collaboration
with the department responsible for purchases, must identify all potential users of the new tech-
nology and meet with them in a timely manner to discuss what criteria are needed and where the
equipment is to be used. The acquisition is either a completely new technology or a replacement of
existing equipment. The clinical needs define the functionalities and characteristics of the technol-
ogy and the clinical engineer can then define the desired specifications; this document describes
the clinical functions that the device is expected to provide, the accuracy of the measurements
or of the output, the list of accessories necessary to operate it, the safety requirements, and any
other information which will enable to compare various devices when companies bid on a request
for proposals (RFP). Cost is one factor, but should not be foremost in the decision except for an
equal performance on all points specified. Sometimes it is important to mention the requirement
for compatibility with other devices that are currently used in the medical facility where the new
technology is to be used. Today, requirements would also frequently specify that the output signal
or data collected be exported and stored for future analysis and research. Ensuring that proper
operating and service manuals are included is critical and the specifications should request service
training if it is needed by the CED staff to maintain the equipment after the warranty expires. All
quotations (bids) must be assessed against the criteria and specifications established for the acquisi-
tion. The final decision on what equipment to purchase should be made by the users in collaboration
with the CED and the purchasing department.

Analysis of Alerts, Potential Hazards, and Incidents Possibly Caused by Medical Equipment

The ECRI Institute issues information called Alerts Tracker on a regular basis to their members.
Equipment manufacturers are also expected to issue alerts or warnings when a problem is discov-
3.2. FUNCTION AND ACTIVITIES OF CLINCIAL ENGINEERING 33
ered. ECRI provides equipment evaluations in a similar way to the Consumer Reports; this can be
useful to consider when acquiring new equipment. A main source for assessing hazards is to consult
the U.S. Food & Drug Administration (FDA) website for recalls of devices and equipment. There
are three levels of recalls: a Class I recall is the most serious, when there is a probability that the
use or exposure to a product will cause serious adverse health consequences or death; a Class II
recall refers to a situation where exposure to a product may cause temporary or medically reversible
adverse health consequences or where the probability of serious adverse health consequences is
remote; a Class III recall is a situation where exposure to a product is not likely to cause adverse
health consequences. Clinical engineers should screen alerts and recalls received and check the in-
ventory of equipment owned by their health care institution to check if any of these were identified
by the alert or recall. A solution has to be applied in a timely fashion depending on the seriousness
of the problem. The manufacturer usually provides what is needed to fix the problem or the device
may have to be sent back to the manufacturer for an update.

Investigation of Incidents or Accidents

Whenever an accident or incident occurs in a hospital, it is important to assess whether a medical

device was involved or not. There may be several reasons other than a defective device for an inci-
dent to occur such as use error, or a combination of circumstances that leads to a problem. However,
medical equipment can be used correctly and still cause a problem if it develops a fault while being
used. The CED should be involved in the process of identifying what happened. One method of
analyzing an incident or accident is to do a simulation, trying to reproduce as closely as possible the
circumstances that led to the problem. Human factors engineering is a useful approach to perform
this type of study (Easty et al. 2009).
When there are incidents or accidents, a report must explain the potential causes and include
recommendations to avoid future mishaps. In cases where a serious injury or death occurs, it is pos-
sible that some institutions require a report from a clinical engineer from a different organization.
The lawyer hired by the institution where the incident occurred also needs to be consulted about
what should be included in the report. Whenever there is an incident or accident that could have
been caused by medical equipment, the clinical engineer should investigate the potential cause in
collaboration with others responsible for this type of investigation.

Training Users on the Safe and Effective Use of Medical Technologies

CEDs should ensure that users receive adequate training from the manufacturer or the distributor
of new equipment acquired. This would normally be done in collaboration with the department
head of the unit concerned. In addition to this, the CED should provide workshops on the safe
and effective use of equipment, on a regular basis, for all staff working with medical equipment.
34 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
This could be arranged with groups and especially include new staff hired during the course of the
year. The frequency depends on the staffing level of the CED and on the needs of the health care
facility. Note that it is not recommended that CE staff operate the equipment themselves as they
are not qualified to perform clinical functions.

Management Functions

The Director of the CED should include in his/her duties the following: ensure that the staff has
the resources needed to accomplish their tasks; prepare and submit the budget that allows the de-
partment to carry-out its functions and activities; evaluate the staff at regular intervals and provide
feedback on how they can improve their work. In addition, to meet the criteria of the Accreditation
of Health Care Facilities, the CED must develop and implement a Continuous Quality Improve-
ment (CQI) program focused on key functions for which the department is responsible. This is
required by the Accreditation Agencies both in Canada and the U.S. There is a difference between
efficacy and effectiveness. A simple way to explain the difference between the two is that the latter
refers to “doing the right things” whereas the former means “doing things right."
It is important for CEDs to measure their productivity and cost-effectiveness. However, this
is quite challenging as there are many ways to assess these and each approach has advantages and
limitations. For an interesting discussion on this topic, see Wang et al., 2012. Measuring the pro-
ductivity of the CED staff is a measure of efficiency. The traditional way to measure productivity
was proposed in several articles in the 1980s and has been a topic of discussion for some 30 years.
Some of the models proposed to assess productivity were:
1. productivity (%) = time worked/time available X 100 (ASHE, 1982);

2. productivity (%) = chargeable hours/worked hours X 100 (Furst, 1987);

3. productivity (%) = earned hours/worked hours X 100 (Bauld, 1987); and

4. productivity (%) = hours worked/available hours X 100 (Frize, 1989), which is similar to
the model suggested by ASHE (1982).
See a detailed discussion on this topic that presents various manners to assess productivity
and issues related to each choice (Wang et al., 2012).
In her study of productivity, Frize (1989; 1990a,b) found that hospital size was not very
useful as a criterion to determine staffing levels of CEDs; this is explained by the fact that hospitals
differ in the number of acute care beds and thus in the amount of equipment needed to provide
care. Equipment inventory size and replacement value were found to be more useful quantitative
parameters to define workload related to the technology management functions.
3.3. A CHANGING ROLE IN THE 21ST CENTURY 35
Although any of the proposed productivity measurement approaches should not be used
alone, as the issue is more complex than indicated by the suggested measurements, it is still useful
for a CED to use a simple approach to assess in a general way if the staffing level is sufficient to
carry out the workload for which it is responsible. One way to do this is to calculate the number
of working days in a year (this excludes holidays, weekends, average vacation days per staff person,
and average sick leave days taken by the staff.) The remaining days are multiplied by the hours of
work per day, minus breaks and lunch. This number should be multiplied by a realistic percentage
that takes into account interruptions, making reports of work done, etc. The final number can be
interpreted as follows: a percentage between 75% and 85% of the total available hours suggests that
the staff is logging in much of their work. Any number higher than 85% would be questionable as
it is not possible to have 100% of recorded productivity. If the technicians justify between 60 and
74% of their time on assigned activities, this is considered acceptable, while recording a percentage
between 50 and 59% indicates a need to find improved efficiencies for some of the tasks, or an easier
way to record the time spent of their tasks; a productivity measurement under 50% is unacceptable.
It is important to use this information with care, as if it is perceived as a close monitoring of the
staff ’s use of time instead of useful statistics to populate the department, resentment can set in and
the information provided may become falsified.
If the recording of the hours spent of various tasks are fairly accurate, then the depart-
ment workload can be calculated by the average hours per year of corrective maintenance, pre-
ventive maintenance, incoming inspections, etc.. This number is then divided by the number of
full-time-equivalent staff. This could enable the CED to assess if it has enough staff to do all the
expected work or to justify hiring more people if it can show that it is understaffed for its level of
activities.

3.3 A CHANGING ROLE IN THE 21ST CENTURY

The role of CEDs began to change in the past two decades. Most medical devices incorporate some
form of computer technology, even for simple thermometers. Increasingly, medical equipment in-
cludes a feature that allows data collection from patients. A new role for CEDS is to help ensure
that the data collection, storage and retrieval is available for clinicians and researchers. This new
systems aspect of the role means that clinical engineers need to work more closely in collaboration
with the hospital’s Information Systems (IS) department who had, until recently, been responsible
for the support of all computer systems such as the administration and payroll systems, a computer-
ized pharmacy system, a patient information system (PIS), and several others as they were acquired
(Zambuto, 2004). Grimes suggests that clinical engineers must act as the “stewards” of health care
technology. As effective stewards, clinical engineers need to understand the practitioners’ intent,
they need to possess knowledge with respect to both existing and developing healthcare technology,
and they must understand the various implications of applying the technology (Grimes, 2004).
36 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
In the past, the IS department and the CED have not really worked closely together. However,
in some hospitals, the CED is responsible for IS staff and the opposite occurs in other sites. The
meshing is not always smooth, but it is the most logical way to ensure an effective transition for
hospitals to a computerized environment for all its functions. The Electronic Medical Record
(EMR) is becoming a common feature and is discussed in Chapter 8 of Part II. Another new aspect
of the CED role is to help reduce medical errors and adverse events through the use of appropriate
information technologies. More details are provided in Chapter 7 of Part II.
Finally, it is a good practice for the staff of a CED department to make rounds and visit
each clinical department, collect feedback on the perception they have of the equipment mainte-
nance and management service provided, and query whether there are other problems that should
be addressed. Many issues and problems can be identified with these rounds or visits and even by
stopping in the corridor or in the cafeteria to chat for a few minutes with users. They often say: “I
was going to call you about this…” Health care personnel are very busy with patient care and equip-
ment issues are not foremost in their mind. So it is a good principle to seek interactions. When all
goes well, this is also good news for the CED, and people come to understand the important role
it plays in the health care team.

3.4 CLINICAL ENGINEERING IN DEVELOPING COUNTRIES

In developing countries, clinical engineering appeared later than in Western countries; this devel-
opment occurred mainly in the late 1980s and early 1990s, except in countries like India and Brazil
where they sprung up in the late 1970s and early 1980s. An international survey was conducted
in 2003 to assess the status of Clinical Engineering Services delivered to hospitals in developing
countries (Cao 2004). Data was collected from Asia, Africa, Latin America, and Mexico. The
responses were compared to two previous studies done in industrialized countries (Frize 1989;
Glouhova 2000). In addition to this study, a model of medical technology acquisition and diffusion
was developed by Roy (2004). Another study was done in 2007-2008 in developing countries with
a much larger sampling than the former study of 2003 (reported in 2004 by Cao) (Mullally 2008).
The results of these three studies pertaining to developing countries are summarized below.
The 2003 questionnaire, available in three languages (English, French, and Chinese) using
close-ended questions and boxes for many of the responses was sent to 700 contact persons in three
regions: Asia, Africa, and Latin America. Sixty-four responses were received. Because of the small
size of the sample, the responses were grouped into two regions: 34 from Asia (India, Bangladesh,
P.R. China, Indonesia, Saudi Arabia, South Africa; and 27 from Latin America (Venezuela, Brazil,
and included Mexico). The proportion of respondents from teaching hospitals was 65% (22/34) in
Asia and 44% (12/27) in Latin America; 80% of departments existed as a separate unit, similar to
the previous Frize survey in industrialized countries which was 81%. More than 80% of respon-
dents were satisfied with their reporting authority. Like other regions studied by Frize (1990; 1994)
3.4. CLINICAL ENGINEERING IN DEVELOPING COUNTRIES 37
and Glouhova (2000), respondents who reported to a “Senior administrator” were more satisfied
than those reporting to a “Plant Director” or a “Medical Director.” Respondents reporting to “other
directors” were also satisfied; this category included “Lab Director,” “University Technology Re-
search Institute,” “Logistic Department,” and “Nursing Manager” (Cao 2004; Frize et al., 2005).
The education level and staff ratio of clinical engineers and technicians varied in the two
regions. In Latin America, staffing was similar to industrialized countries, where technicians made
up the majority of the staff. Clinical Engineers had at least a BSc, but a few had a MSc. or a Ph.D.
In previous studies in industrialized countries, just over 60% of clinical engineers had a MSc. or a
Ph.D., compared to 6% in Latin America and 4% in Asia. In Asia, the education level of clinical
engineers was lower; 12% did not have a university degree, and fewer had an MSc. or Ph.D. degree
than in Latin America. A few CEDs in Asia employed more clinical engineers than technicians,
and a third (10/34) employed only technicians; 12% of CEDs in Latin America hired only clinical
engineers (Frize et al., 2005).
The education level of technicians in Latin America had a slightly lower education level
than Asia. The highest education in Asia was 3-year technical school after high school, compared
to 2-year technical school in Latin America. But both regions showed a lower level of education of
technicians than industrialized countries, where a number of technicians had a 4-year technical ed-
ucation. Only 26% (16/61) of respondents were members of professional or technical associations;
90% of CEDs in both regions trained their staff at special centers and/or on the job. Some respon-
dents reported that manufacturers and dealers provided some of the training (Frize et al., 2005).
The number of devices and their replacement value managed by CEDs in developing coun-
tries were substantially lower than in industrialized countries. Repairs, incoming inspections, pre-
ventive maintenance, user training, and pre-purchase consultations were all activities performed by
CEDs. However, research activities were not common. This differed somewhat from industrialized
countries.
In terms of workloads, clinical engineers in this survey spent 40% of their time on equip-
ment repairs, while those in Frize’s survey spent the same amount of time on consulting activities.
Technicians in the present study spent more time on repairs, incoming inspections than those in
Frize’s study, and less on preventive maintenance; their main responsibility was equipment repair. In
Asia, clinical engineers performed more repairs than technicians; perhaps their qualifications were
more like those of technicians in industrialized countries. This was not observed in Latin America.
There were other responsibilities reported such as “bio-safety,” “administrative tasks,” “collaborative
project,” “tracing suppliers.” “Administrative tasks” were frequent in Latin America with a workload
ranging from 15%–68%; perhaps this coincides with the low hiring of clerical staff (Frize et al.,
2005).
There were 30% (18/61) of CEDs stating that they did not have adequate manuals for equip-
ment management. Compared with Latin America, Asia had a higher need of the manuals: 41%
38 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
(14/34) vs. 15% (4/27). Some of the reasons given by respondents were: “need more specific man-
uals,” “need electric circuit diagrams,” “need manuals in our local language,” and “incoming devices
without manual.” On the question regarding the adequacy of their test equipment, spare parts, and
space allocation per person, respondents in both regions differed from responses in industrialized
countries; most respondents stated having inadequate resources, except for space allocation in Asia;
while most respondents in the two developed country studies thought they had adequate resources.
In the present survey, CEDs in Asia were satisfied with their space allocation when they had 15
square meters per person, while CEDs in Frize’s survey were satisfied only with 20 square meters
per person.
In this survey, all respondents who used computers for their equipment management were
in Latin America, whereas all respondents who used manual records were in Asia. One third of
CEDs using computers developed the software themselves. Almost all (98%) respondents in this
survey stated having at least one computer in the department, and 96% (26/27) of Latin American
respondents said they could always access the Internet from their departments. However in Asia,
only 47% (16/34) had Internet access and all respondents stated not being able to go online. Quality
assurance was carried-out by 70% of respondents in both regions; 80% of respondents in Asia had
begun to perform productivity assessments, while 37% of Latin American respondents had begun
to do this. In the survey, only 44% (20/45) of respondents felt recognized in their hospitals, which
was similar to the earlier Frize study (1990). However, in the later Glouhova study (2000), more
than 80% of respondents felt they were recognized.

3.4.1 A MODEL TO ASSESS THE READINESS OF A COUNTRY TO

ACQUIRE, DIFFUSE, MANAGE MEDICAL TECHNOLOGIES
In her study, Roy examined e-commerce and e-government models, but none had been applied to
a medical equipment situation. Roy developed a preliminary model to assess a developing country’s
readiness to acquire, diffuse, and manage medical technologies (Roy, 2004). Two countries with a
vast difference in their level of development were used to construct the model. The model’s attri-
butes were extracted from data collected on Mali and Brazil. The data came from both primary
and secondary sources, obtained mainly from CIDA (The Canadian International Development
Agency). Data was collected on:
1. the principal health care concerns;

2. government spending in health care per capita;

3.4. CLINICAL ENGINEERING IN DEVELOPING COUNTRIES 39
3. whether the country had a strategic plan and/or policy to manage its health care system
and equipment acquisition and management;

4. whether the country regulated the acquisition, use, and diffusion of medical devices;

5. whether there were internet and telephone services available to the population and to
health care facilities;

6. organizational capabilities to manage the technology; and

7. health technology diffusion, and the level of technology available in the country’s health
care system.
Attributes that contributed to substantial health-related advancement were considered as en-
ablers and the opposite were constraints. The seven categories of attributes were studied for each of
the two countries and the results provided a risk rating of high, medium or low with regards to the
potential failure or success of funding health-related projects in these countries. This research filled
an urgent need for agencies like CIDA to evaluate the risk of potential investments in health-re-
lated projects. Roy’s study also identified areas that Mali and Brazil should address to improve their
medical technology readiness assessment. In the case of Brazil, connectivity for rural areas would
support further deployment of medical technologies. In the case of Mali, the need was pressing in
all qualifiers/enablers. The areas requiring improvement could become the object of future donor
programming in the country (Roy, 2004). Decision-makers can pay particular attention to the
enablers that scored high if they relate to the implementation of an initiative. For example, when
considering an initiative related to medical staff certification in Mali, it is important to consider
that the regulatory function is weak. The team should then include components that address those
identified as high risks in their design.
The application of the medical technology assessment model to Brazil and Mali was en-
couraging. It provided a simple framework, recommending the avoidance of certain technologies
because the country was not ready to adopt and sustain them. An interesting observation from this
work was the trade-off between complexity and benefit; medical technologies stood to have the best
health benefit at the primary care level. Paradoxically, that is where implementation and sustaining
effort needed are more difficult. Another observation was that there probably exists a correlation
between a country’s medical technology readiness and its focus on health. An assumption would be
that countries focusing on curative health are less likely to absorb and sustain new medical tech-
nologies than the ones which include a preventive focus (Roy, 2004).
40 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
3.4.2 TECHNOLOGY MANAGEMENT
Returning to the issue of technology management, although the number of respondents
from developing countries in Cao’s survey was not very large, the results were useful to assess where
countries stood in terms of resources, responsibilities, and recognition. The study enabled CEDs in
all developing countries to define their workloads and thus they could request appropriate resources.
Roy’s model to assess readiness of countries to acquire and diffuse medical technologies helps to
identify weaknesses and the level of equipment sophistication that a country can sustain success-
fully. Both studies can help developing countries to strengthen all aspects of medical technology
management needed to improve health care delivery to their populations (Frize et al, 2005; Roy,
2004; Cao, 2004).
A new study in 2007-2008 collected 169 responses from 43 countries on clinical engineering
effectiveness in hospitals. The responses were primarily from Africa, Latin America and Asia, with
some representation from the Middle East and Eastern Europe. The data identified hospital and
clinical engineering department profiles, human and equipment resources, equipment procurement
and donation processes, with a focus on the role of the clinical engineering department (Mullally,
2008). Some of the findings were:
• Teaching hospitals accounted for 27.2% of overall responses; the most common hospital
type was publically funded (40.2%) and 22.5% were private; philanthropic/non-govern-
mental organizational hospitals were 9.5%. In Africa, the hospital size was 50-200 beds,
in Latin America, they were 50-250 beds with some larger ones 250-500 beds; in Asia,
the majority of hospitals had over 500 beds; in the Middle East and Eastern Europe,
most had 250-500 beds with a few over 500 beds (Mullally and Frize, 2008).

• Only 57% of CEDs surveyed in this study existed as a separate unit, which is much lower
than found in industrialized countries. A minority of departments (36% or 45/125)
shared maintenance services with other hospitals. The majority of these (66.7%) reported
being the main center of service.

• Regarding staff levels, all regions claimed not having adequate staff to carry-out their
workload. When asked if CEDs had difficulty in finding qualified engineers and tech-
nicians, all responded yes. For the difficulty of finding engineers, 79% of respondents
from Africa and Latin America said yes; in Asia, the proportion was lower: 56.5%. In
the Middle East and Eastern Europe, this was the highest at 83.3%. For finding qual-
ified technicians, 70% of respondents in Africa and 77.6% from Latin America needed
to find staff with these qualifications; in the remaining regions, the proportion was 60%
(Mullally and Frize, 2008).
3.4. CLINICAL ENGINEERING IN DEVELOPING COUNTRIES 41
• A strong determinant of CED effectiveness is the level of involvement in the equipment
acquisition process. 80% of participants reported the existence of an official procurement
policy at their hospital, and almost half were “very” involved in the process. Regarding
who led the procurement of equipment process, and who was involved in the team, see
Table 3.1.

Table 3.1: Proportion of type of personnel involved in leading and in the decision-making process
for equipment acquisitions (Source: Mullally 2008)
Personnel Leads the process Involved in decision
Administrator 45.7% 53.3%
User 27.6% 71.4%
Consultant 8.6% 36.2%
CED manager 30.5% 67.6%
CED staff 10.5% 53.3%

The majority of equipment was procured through a formal acquisition process (median of
90%), while donations accounted for 5%, leases, rentals, and loans amounted to another 5%. Do-
nated equipment often arrived without appropriate resources. The proportion of respondents who
claimed that spare parts never accompanied donations (n=63) was 58.7%; for user manuals, 29.7%;
for maintenance manuals, 42.2%; for user training, 50.2%; and maintenance training, 61.3%. Often,
there was little to no consultation with recipient hospitals when equipment was donated. The level
of consultation with the hospital before a donation occurred was rated by respondents as “fair”;
however, 36.2% reported that there was no consultation at all.
These studies have been helpful in assessing the level development of clinical engineering in
both industrialized and in developing countries; it also enabled to identify their level of integration
into the health care team and the resources they are given to perform their role. The data can help
CEDs to develop a plan to move to the next level of involvement and to apply for the resources
needed to get there.

3.4.3 WHO BASELINE COUNTRY SURVEY ON MEDICAL DEVICES (2010)

In 2010, the WHO carried-out a survey in 196 countries, receiving 144 responses. The survey re-
sults were reported at the First WHO Global Forum on Medical Devices held in Thailand in 2010
(WHO, 2011). The survey asked whether countries had: a national policy for health technology;
guidelines for donations; technical specifications for procurement or donations; a national list of
approved medical devices; a medical equipment management unit; and availability of high cost
medical devices. For more details, see the entire report which also contains 42 recommendations
for future actions (WHO, 2011).
42 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
The next chapter discusses safety considerations, minimizing liability, and continuous quality
improvement program design.

REFERENCES
AAMI (n.d.). “Association for the Advancement of Medical Instrumentation.” Available at: www.
aami.org/; last accessed July 2013.
AAMI_Certification. Available at: http://www.aami.org/certification/about.html; last accessed
September 2013.
ACCE (n.d.). “American College of Clinical Engineering.” Available at: http://www.accenet.org/;
last accessed July 2013.
American Society for Hospital Engineering (ASHE) (1982). “Part II: Determining Productivity,
in Medical Equipment Management in Hospitals.” Edition. Chicago, II, ASHE: 2-7.
Bauld, TJ (1987). “Productivity: standard terminology and definition.” J. Clin. Eng., 12: 139-145.
DOI: 10.1097/00004669-198703000-00014.
Cao, X (2004). “Assessment of Clinical Engineering Department in Developing Countries.” MASc
Thesis in Systems Science, University of Ottawa.
CMBES (n.d.). “Clinical Engineering Standards and Practice.” Published by the Canadian
Medical and Biological Engineering Society. Available at: http://www.cmbes.ca/index.
php?option=com_content&view=article&id=80&Itemid=99; last accessed July 2013.
Dyro, JF (1988). “Clinical Engineering: A Prospectus.” s.l., IEEE: 80-85.
Dyro, JF (2004). Clinical Engineering Handbook. Ed. Elsevier Academic Press.
Easty, AC, Cafazzo, JA, Chagpar, A (2009). “Improving safety in healthcare through the estab-
lishment of a healthcare human factors team.” In World Congress on Medical Physics and
Biomedical Engineering, September 7-12, Munich, Germany, Springer Berlin Heidelberg:
324-327. DOI:10.1007/9783642038853_90.
ECRI Institute,(n.d.). https://www.ecri.org/Pages/default.aspx; last accessed July 2013.
FDA (n.d.). “U.S. Food and Drug Administration.” Available at: www.fda.gov; last accessed July
2013.
Frize, M (1988). “The Clinical Engineer: A Full Member of the Health Care Team?” Med. Biol.
Eng. Comput. 26: 461-165. DOI: 10.1007/BF02441912.
Frize, M (1989). “Evaluating the effectiveness of clinical engineering departments in Canadian
hospitals.” Doctoral dissertation, Erasmus Universiteit, Rotterdam, The Netherlands.
3. REFERENCES 43
Frize, M (1990-a). “Results of an international survey of clinical engineering departments Part 1.”
Med. Biol. Eng. Comput., 28: 153-159. DOI: 10.1007/BF02441771.
Frize, M (1990-b). “Results of an international survey of clinical engineering departments Part II.”
Med. Biol. Eng. Comput., 28: 160-165. DOI: 10.1007/BF02441772.
Frize, M (1994). “Longitudinal study of clinical engineering departments in industrialised coun-
tries (1988 to 1991).” Med. Biol. Eng. Comput., l32: 331-335.
Frize, M, Cao, X, Roy, I (2005). “Survey of Clinical Engineering in Developing Countries and
Model for Technology Acquisition and Diffusion.” Proc. IEEE/EMBC Shanghai: 171-
173. DOI:10.1109/IEMBS.2005.1616369.
Furst, E (1987). “Guest Editorial—special issue: productivity & cost-effectiveness.” J. Clin. Eng.,
12: 99-100.
Glouhova, M, Kolitsi, Z, Pallikarakis, N (2000). “International survey on the practice of clinical
engineering: mission, structure, personnel, and resources.” J. Clin. Eng., 25(5): 205-212.
DOI: 10.1097/00004669-200025050-00009.
Grimes, SL (2004). “Clinical engineers: stewards of healthcare technologies.” Eng. Med. Biol. Mag.
IEEE, May-June, 23(3): 56-58. DOI: 10.1109/MEMB.2004.1317982.
HTF (n.d.). “The Healthcare Technology Foundation.” Available at: http://www.thehtf.org/; last
accessed July 2013.
IFMBE (n.d.). “Clinical Engineering Division.” Available at: http://ifmbe.org/organisation-struc-
ture/divisions/clinical-engineering-division/; last accessed July 2013.
McEwen, JA (1982). “Clinical engineering and hospital accreditation in Canada.” J. Clin Eng., 7(1):
83-85. DOI: 10.1097/00004669-198201000-00011.
Mullally, S (2008). “Clinical Engineering Effectiveness in Developing World Hospitals.” MASc
Thesis in Electrical Engineering, Systems and Computer Engineering, Carleton Univer-
sity, Ottawa.
Mullally, S Frize, M (2008). “Survey of Clinical Engineering Effectiveness in Developing World
Hospitals: Equipment resources, procurement, and donations.” Proc. IEEE/EMBC, Van-
couver: 4499-4502. DOI: 10.1109/IEMBS.2008.4650212.
Nader, R (1971). “Ralph Nader’s Most Shocking Exposé.” Ladies’ Home J., 3: 98-179. DOI
10.1007/BF02368486.
NFPA (n.d.). “National Fire Protection Association.” Available at: www.nfpa.org; last visited Sep-
tember 2013.
44 3. MANAGEMENT OF MEDICAL TECHNOLOGIES
Ridgway, MG, Johnston, GI, McClain, JP (2004). “History of Engineering and Technology in
Health Care.” 9-10. In Dyro, JF (2004) Clinical Engineering Handbook. Elsevier Aca-
demic Press.
Roy, I (2004). “Medical Technology Assessment Model for Developing Countries.” MASc Thesis
in Telecommunications Technology Management, Carleton University.
UL (n.d.). “Underwriters Laboratory." Available at: www.ul.com; last visited September 2013.
Wang B, Rui T, Fedele J, Balar S, Alba T, Hertzler LW, Poplin B (2012). “Clinical Engineering
Productivity and Staffing Revisited. How Should It Be Measured and Used? J. Clin. Eng.,
October/December: 135-145.
World Health Organization (2011). “First WHO Global Forum on Medical Devices: context,
outcomes, and future actions. Available at: http://whqlibdoc.who.int/hq/2011/WHO_
HSS_EHT_DIM_11.11_eng.pdf; last accessed September 2013.
Zambuto, RP (2004). “Clinical Engineers in the 21st Century.” IEEE Eng. In Med. & Biol. Maga-
zine, 23(3): 27-31. DOI:10.1109/MEMB.2004.1317980.

Safety Considerations, Minimizing

Liability, and Continuous Quality
Improvement (CQI)
In this chapter, we examine the safety of patients and staff in health care institutions, more specif-
ically electrical safety and hazards created by electromagnetic interference (EMI). The question of
liability is discussed as well as how to minimize exposure. The last part of the chapter provides a
short overview of quality assurance leading to a continuous quality improvement (CQI) program
for Clinical Engineering Departments.

4.1 ELECTRICAL SAFETY IN HOSPITALS

Each country has its own standards and regulations regarding electrical safety in hospitals and other
health care institutions. In Canada, the Canadian Standards Association (CSA) developed stan-
dards and regulations, not only concerning the distribution of electricity in the building, but also
concerning the level of leakage current permissible on equipment found in patient areas, whether
these are devices used in patient care or not. Hospitals in Canada are obligated to have all electrical
supply and devices meet CSA requirements and all equipment entering the hospital must be CSA
approved or tested.
In the United States, there are several laws, regulations, and codes that apply to the safety,
maintenance, and management of medical technologies. The government body entrusted with
the responsibility to regulate medical devices and drugs is the U.S. Food & Drug Administration
(FDA). The FDA’s primary task is to review the safety and efficacy of drugs and devices prior to
their introduction into the market. Manufacturers are required to perform registration, labeling,
and good manufacturing practices and to report adverse effects. The FDA is also involved with
performance standards and pre-market approvals.
The Association for the Advancement of Medical Instrumentation (AAMI), in collaboration
with The American National Standard Institute (ANSI), developed the standard: ANSI/AAMI
ES60601-1:2005, Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and
Essential Performance. The third edition of the standard covers any medical device that requires an
electrical outlet or a battery (AAMI).
The National Fire Protection Agency published NFPA 99 – Standards for Health Care Facili-
ties (NFPA, 2012). Although it is a voluntary standard, NFPA 99 has been adopted by many states,
46 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
counties, and municipalities through reference in their licensing requirements, thus becoming man-
datory requirements for hospitals, but not necessarily for the manufacturers and other organizations
located outside of health care facilities.
The 2012 NFPA 99: Health Care Facilities Code and Handbook Set addresses the safety of
patients, staff, equipment, and facilities; it covers a wide range of systems within healthcare such
as electrical, gas and vacuum, environmental, materials, electrical equipment, and gas equipment;
it also discusses other hazards such as fire and explosion, burns, chemical, and radio-frequency
interference. The section on electrical equipment specifies certain design and construction criteria,
as well as periodic tests and inspections, and contains requirements for user and service manuals,
service documentation, and qualification and training of users and maintainers (NFPA.org).

4.2 BRIEF SUMMARY OF ELECTRICAL SAFETY ISSUES

Every device powered by electricity has leakage current that originates from capacitive, inductive, or
resistive sources and can be present on the chassis or accessible metal parts of the device. This is not
necessarily due to a fault and is normally channeled safely by a third wire connected to the ground.
However, if the ground wire is broken, the leakage current on the metal parts of the device can be
channelled through a patient connection and cause an electrical shock; if the level of this current
is high due to a short or a fault, this can be dangerous for patients and staff, especially if there is
a connection to the heart. There can also be a voltage difference between two devices connected
to a patient, which may cause a leakage current to flow from one to the other through the patient.
A macroshock is an electrical current which flows on the outside parts of the body; this can
be dangerous if the current level is sufficiently high and if it passes through the region of the heart,
as between an arm and a leg. The body response to various levels of current has been documented by
a few studies: A tingling sensation can be caused by a current of 0.5–2 mA; a 20 mA current causes
a “no-let-go” situation, which means that the person cannot disconnect from the source. At 50 mA,
there can be respiratory distress; 100 mA can lead to ventricular fibrillation, which can cause death
if not reversed within a few minutes (Roy, 1980).
A microshock is a current that is applied to an internal part of the body near the heart. This
can be sent through a catheter lodged near the heart, with metal contacts outside of the body, as
with temporary pacemaker leads. In this case, the current level of 100 µA is reported to be able
to cause a ventricular fibrillation. The body is more sensitive to currents and voltages that are in
the frequency range of 50–60 Hz. Other common examples of potential internal connections are:
intra-cardiac ECG leads, a fluid-filled line into an artery or a vein, or a pulmonary artery catheter
such as a Swan-Ganz line connected to a pressure transducer, and drug/dye injections. For more
details on the effect of current on the human body, see Roy, 1980.
4.2. BRIEF SUMMARY OF ELECTRICAL SAFETY ISSUES 47
4.2.1 ENSURING ELECTRICAL SAFETY
The best way to ensure that all devices are safe to use with patients and staff rests with proper design
and manufacturing. However, it is also important to establish a schedule for safety tests on medical
equipment in case a fault has developed or if the ground wire has been damaged over time. This
entails measuring the leakage current and assessing whether it meets the various standards and reg-
ulations; it also tests if the ground wire in in good condition, that is, has an almost zero resistance.
If the level of current is found to be higher than the acceptable limits for both microshocks and
macroshocks, depending on the intended use and the presence of an internal connection or not,
then a solution must be found. An isolation transformer can be added to limit the leakage current
on the patient leads and chassis; another approach is to ensure all metal parts that can carry current
are covered with an insulating material. If the equipment is very old, it could be decommissioned.
Optic coupling for monitors is now a common way to isolate the patient from the electrical power
circuit of the device.

3.2.2 ELECTRO-MAGNETIC INTERFERENCE (EMI) AND MEDICAL

DEVICES
This section presents a brief historical review of the issues and discusses the EMI environment,
that is, sources of EMI that can interfere with medical devices. Examples are provided of medical
devices that can malfunction when in the presence of EMI. Some solutions are suggested to protect
the devices from EMI and patients from potentially hazardous malfunctions.

The EMI Environment

Sources of EMI that can be present in a health care environment, or near patients who are con-
nected to medical devices or who have devices implanted in their body, are presented below.

Sources of EMI

There are many sources of interference, such as local high power AM/FM and TV transmitters,
paging systems, cellular telephone base stations and repeaters, two-way radios, amateur or CB radio,
wireless communication devices, microwave ovens, and static discharge from humans. In the oper-
ating theater, there are electrosurgical generators and electric drills; in physiotherapy departments,
we find diathermy, ultrasound therapy, and interferential therapy machines. All of these sources
produce EMI that can be measured in Volts per meter. It is obvious that the closer the patient is to
the source, the higher will be the emitted signal. The signal strength (usually in volts per meter) is
divided by the square of the distance from the source. Medical data transmitted by wireless teleme-
try is another potential source of interference and is also vulnerable itself to interference from other
48 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
devices. The transmission frequency of telemetry systems is usually selected in a way to minimize
these problems.

Potential Impact of EMI on Medical Devices

The best way to demonstrate this potential danger is through examples. Take a patient with an im-
planted pacemaker of the “demand” type. This means that the pacemaker assesses the time between
heart signals (ECG), and if this is longer than expected, it provides an impulse to the SA node and
the heart then goes through its normal cycle. However, if there is an EMI signal, this can resemble a
heart signal and so the pacemaker can remain silent. One can see that with continuous EMI signals
present and an SA block, where the patient’s heart does not pace by itself, then the patient can die.
The same situation applies to an apnea monitor that measures the time between breaths; if there
is an apnea (no breathing) and EMI signals are present, the apnea monitor can be silent and not
sound an alarm. Again, if this lasts for a few minutes, the patient can die. An implanted defibrillator
is also another device that can stop functioning properly in the presence of EMI.
Other types of medical devices can malfunction in a different manner. For example, patient
monitors can lose their signal and stop monitoring the patient. This is a problem in the operat-
ing theatre when drills or electrosurgical generators are used. The anesthetist needs to have the
signals on the monitor to assess how the patient is doing under the anesthetic agent and gases
being administered. A good practice is for the surgeon to use the electrosurgical generator in
spurts of 30 s or less; in this way, the monitor can regain its signals between the use of cutting
and coagulation functions of the electrosurgical generator.
Infusion devices can be a serious problem as they can be reprogrammed to open flow by some
EMI signals. If the drug being administered is potent, this can kill the patient or do some severe
damage that may or may not be reversible. Artificial ventilators can also be reprogrammed and
change the breath rate, which can cause severe problems for patients. Pulse oximeters may have false
readings and incubators and radiant warmers can stop working or be reprogrammed. Some types
of hearing aids can send loud signals to patients wearing them. It is also known that electrically
powered wheel chairs can veer off course suddenly when in the presence of an interference signal;
they can experience incidents of uncontrolled movement or electromechanical brake release that
can lead to serious injury or death (Witters 2009).
It is important to note that EMI issues change with time and environment. Some hospitals
or patients using medical devices at home are located in areas with transmitting sources, while oth-
ers are in areas with no or low level sources. It is expensive to monitor EMI and it is frequently in-
termittent, so it may be quite difficult to capture. Devices can also behave differently in a laboratory
when we try to reproduce the situation. Another issue is that physiological and biological signals
are typically very low (in the order of mV or µV). We must use high gain amplifiers to be able to
observe the signal on an output device. Leads, cables, and the human body can act as an antenna
4.2. BRIEF SUMMARY OF ELECTRICAL SAFETY ISSUES 49
that captures the interference signals. There is also the phenomenon of the coupling of signals and
rectification signals at electrode-skin interfaces.
Users (patients and the health care team) need to be aware of potential problems caused by
EMI; they must question whether this is present when a malfunction occurs and report the event
to the appropriate authority (especially to biomedical staff if they exist in the health care facility)
to ensure others become aware of the problem detected.

Electro-Magnetic Compatibility (EMC)

EMC is the opposite of EMI. It refers to the level of EMI that a device can be subjected to without
its proper functioning being disrupted or altered. In general, medical devices are expected to have
an EMC of 3 V/m for both non-life and life support devices (IEC standard, 2004).
When problems are observed in a certain location with a specific device, say an EMG
(electromyograph) signal collection and recording instrument, there is a solution: move the EMG
device to a more EMI quiet location or remove the source of EMI. For example, in the 1970s, in
a hospital in Montreal, the EMG equipment was reproducing radio signals instead of the patient’s
signals. On the other hand, the ECG department had very little or no EMI in their location. The
two departments (ECG ad EMG) agreed to switch their location and the problem was solved.
ECG signals do not experience EMI issues to the same extent as EMG signals. The hospital was
located near major television transmission antennas. Some people suggested installing a Faraday
cage, but I disagreed as this is a very expensive proposition and difficult to implement properly with
just one single ground and no ground loops. A better solution is to carefully select the location of
devices where the biological signals are very small. Tests can be done to see if the EMI signals are
low for such clinics. Testing equipment is very expensive but perhaps can be borrowed for the tests
when deciding to do renovations or when moving clinics to other locations. My solution in the
1970s and 1980s, since I could not easily find test equipment to borrow, was to connect a coil to my
oscilloscope and see where interference signals were picked up and whether they were low or high.
This was a crude approach, but it worked in the case of relocating the EMG clinic.

Classification of EMI incidents

Researchers use the term true positive when they can replicate an incident at a site and/or in a
laboratory, which increases the degree of confidence on the nature of the particular incident. A false
positive is an incident that is attributed to EMI, but is probably not due to EMI; it is perhaps a
software problem or another type of malfunction. A false negative is a situation where an incident
is not attributed to EMI, but it is likely occurring because of EMI; this often happens if the person
reporting the incident is not familiar with the concept of EMI; sometimes this is subsequently
50 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
confirmed by an alert from the manufacturer, or from organizations like the FDA in the U.S. or
Medical Device Bureau in Canada.
As we saw previously, EMI can cause a variety of problems: devices operating outside of
their specifications; operator intervention may be needed; or a fault may need a repair. The device’s
operation can be out of control; there can be a silent malfunction (no alarm or not functioning at
all); or there can be a discrepancy between a clinical reality and the readout of the device. At other
times, it may be impossible to read the signals, as in the example of the EMG machine discussed
above. Moreover, some devices are unreasonably susceptible, so this should be checked when buying
new devices. The FDA website can be consulted for a description of many EMI incidents that were
reported to that agency (FDA.org).

4.3 LIABILITY EXPOSURE

This section discusses the liability exposure to malpractice suits in the health care field for clin-
ical engineers and technicians. Approaches are suggested to minimize exposure. One question is
whether personal malpractice liability insurance is needed. In general, it may not be necessary to
buy this unless someone is an independent consultant. Hospitals should usually cover their employ-
ees under their own liability insurance policy. It is possible for the engineer to be sued individually
for personal negligence, but this type of insurance is very expensive and not really a practical ap-
proach for a clinical engineer’s salary range. But if engineers are in private practice, then it may be
advisable to obtain coverage.

4.3.1 HOW TO MINIMIZE RISK

One way to minimize the risk of exposure is to ensure that the CED’s program of activities is well
planned, implemented, up-to-date, and meets all legal requirements in their region or country. It is
especially important to keep documentation on the development of the department, of each inter-
vention made by staff, and of each incident reported; the reports should include recommendations
on how to avoid the recurrence of accidents or incidents.
The type of documentation that should be provided to the management team concerns the
appropriateness (or inappropriateness) of purchases made by the hospital, compliance with codes
and regulations, safety policies and tests, and records of the education and training of the depart-
ment’s personnel. Documents should mention what technical documents are available; describe
the equipment management program, and what tests are done to limit exposure to liability; other
documents that should be included are: reports of maintenance and repair costs; departmental
performance (staff, budget, etc.); departmental objectives; departmental growth; and up-to-date
information on potential hazards.
4.3. LIABILITY EXPOSURE 51
4.3.2 LEGAL ISSUES IN CLINICAL ENGINEERING PRACTICE
If a medical device causes an incident or accident, it is important to assess whether the product fails
to meet reasonable expectations of the consumers (users) and, as a result, was the proximate cause
of an injury. This can refer to an item, a piece of equipment, a device, the supply of services, or even
a building. It can also refer to a procedure or a system.
A defect usually refers to a defective design or a failure to warn of certain hazards. A defective
design can be in the specifications or blueprints, or appear in the composition, the process of man-
ufacturing, testing, or inspection. Questions are: Did the device meet the standard of design and
development? Is it safe for its intended use, with reasonably anticipated considerations? Is a safe or
better design feasible? Does the device (design) create an unreasonable risk of harm?
Another aspect is the failure to warn; here we should consider the likelihood of an accident
and the degree of danger created when it is used without a warning. We should also consider the
feasibility of adopting a more effective warning. However, there is no duty to warn if the danger is
obvious to the user such as “a knife is sharp.” There is also no duty to warn against the abnormal
use of the device.
Nevertheless, if there is an obvious danger or an unusual use is foreseeable, the courts may
say there was a duty to warn; this depends on the utility, or severity of potential injury, the cost or
ease of providing the warning, and the level of reduction of the danger with the warning. If the
danger is not known, it may depend on the scientific knowledge of the time, whether a suspicion of
danger exists, to decide on the practicality of adding an effective warning. If a warning is warranted,
another consideration is the extent to which the warning must be communicated to potential users.
If there is a duty to warn, to whom should the warning be addressed. Aspects to consider
are: the physical adequacy of the warning, its prominence, clarity, completeness, and method of
transmission. Compliance with statutory, regulatory, and/or industry-wide standards does not nec-
essarily avoid liability exposure. The duty to warn is a continuous process; it depends on progress,
development and availability of new information; designers must alert users of discoveries either in
the form of product notes, newsletters, letters to users, through persons in their sales force, or with
labels; all of these approaches must be kept up-to-date.
For product liability, negligence can be avoided by exercising due care in design, manufactur-
ing, distribution, testing, and marketing of devices. The most frequently used avenue is the case of
strict liability. For example, if a failure is material in nature, the person responsible for this is held
liable to the individual injured, as a result of a negligent conduct.
In engineering, due care means a careful evaluation of the concept, plan, materials used, pro-
cess of manufacturing, testing, inspection, and the need for safety measures. If unavoidable danger
exists, the duty to warn or to provide direction on its use is expected. The concept of negligence
refers to the absence of due care or the failure to exercise due care.
52 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
In cases of strict liability, the injured party must prove that damage resulted from a condition
of the product; or a condition was unreasonably dangerous; or an unreasonably dangerous condition
existed at the time it left the defendant’s control. It is not required that a fault be established in
order to justify a recovery under strict liability. Misrepresenting a material fact about a product is
answerable in damages through negligence and strict liability.
A tort is a legal wrong committed upon a person or property independent of any contract;
this applies to negligence and strict liability.
A case of a breach of warranty is contractual in nature and is said to be the least frequently
chosen in court cases. A warranty is an implied or expressed promise.
A legal defense would attack the basic elements of the proof required by the injured party,
which normally would establish a defect or a duty to warn, or the need for a safety device. The
amount of recovery may or may not be affected by the injured party’s conduct at the time of the
incident.
Contributory negligence is a failure to exercise due care to discover defects or to guard
against their existence. This is of great importance for clinical engineers; their role is to minimize
hazards and to screen alerts.
Product liability is of importance to manufacturers and distributors of equipment. Informa-
tion on this topic is available from the FDA and from an article by Keeton (1972). Also, a detailed
description of product liability can be found in the legal dictionary by Hill and Hill (1981-2005).

4.4 QUALITY ASSURANCE AND CQI

Quality assurance (QA) has been an integral part of hospital services for several decades and all
departments are expected to develop a continuous quality improvement (CQI) program. When this
requirement was added to guidelines for hospital accreditation, the term used was Quality Assur-
ance (QA), which measures how well a function is being carried-out.
QA applies to services, not to products; it implies a measure of the level of service provided
by a department or a group and a method to identify if additional efforts would improve the level
of service and its quality. It must provide a guarantee that the level of excellence resulting from the
QA program produces an acceptable level of patient care.
Clemenhagen (1985) provided suggestions on how to make such programs work. The au-
thor stated that an important ingredient for a successful implementation was a strong interest and
commitment from the staff to be involved and to develop a program that applies to their particular
service. Other advice was that staff must understand and believe in QA and focus on solving prob-
lems that are relevant and useful. A strong coordinating body is critical to ensure the integration
of all the diverse programs into a whole that is relevant and appropriate for the hospital and its
patients (Clemenhagen 1985).
4.4. QUALITY ASSURANCE AND CQI 53
4.4.1 HOW TO MEASURE QAA
After having identified a situation, a service, or an activity that can be improved, a comparison is
done between actual results recorded and pre-established performance criteria for that activity or
service. If it is not achievable, then poor morale will ensue. The goal is to increase the quality of the
service; it should not be too easy to reach, otherwise the QA becomes meaningless. It is important
that the criteria be realistic and achievable, and that it can be done with the resources available.

4.4.2 GENERAL GOAL

The general goal is to increase the effectiveness, efficacy, and quality of services to ensure the deliv-
ery of good patient care. The hospital’s mission should form an integral part of a QA program. For
clinical engineering departments, specific goals should be:
• ensure equipment is available and working within its specifications and safety standards
for patient care;

• identify additional services needed which are not provided at this time;

• improve the efficacy and competence of the technical staff;

• minimize risks for patients and staff through training staff on the safe and effective use
of medical devices;

• improve the comfort of patients if possible when this is related to the use of technology;
and

• simplify procedures as much as possible to minimize use errors.

The QA program must measure each type of activity and task performed by the CE depart-
ment, including those of the engineers, technologists, clerks, and secretaries.
QA programs for CEDs can be applied to the activities such as: purchase of equipment,
incoming inspections, preventive or corrective maintenance, and analysis of incidents and accidents.
The steps to follow when developing a QA program are:
• identify each task and activity that needs to be assessed;

• define the criteria of performance or select the indicators of quality for the activity; and

• compare the criteria to existing standards (if these exist).

54 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
4.4.3 EXAMPLES OF QA MEASURES FOR CEDS

Incoming Inspections

Assume the following standard: 100% of new devices must undergo an incoming inspection. If
the actual measurement shows that 80% of new devices were inspected by the CED, in the past
6 months, this result is not in compliance with the standard. The next step would be to develop
corrective measures. Possible corrective measures could be:
1. to communicate the problem to the purchasing and receiving department to ensure
that all deliveries of new equipment, or equipment to be evaluated prior to a purchase,
or equipment returned after an external repair be sent to the CED for an incoming
inspection;

2. to ensure the CED staff complies and carries out the proper incoming inspections in a
timely manner on all devices delivered to the CED; and

3. to repeat this audit in a few months to measure if there is an improvement in the pro-
portion of devices tested when they are delivered to the health care institution.

Preventive Maintenance

Assume the following standard: 100% of critical care equipment will be submitted to a preventive
maintenance according to the planned schedule (such as the one recommended by the manufac-
turer) and 80% of all the other equipment will be tested once per year or after a repair. If the actual
measurement is not in compliance, here are some possible corrective measures.
1. Assess the resources available and the workload that the standard as defined above
would require.

2. Communicate to health care staff the importance of testing this critical care equipment.
Sometimes caregivers are reluctant to let their devices be taken temporarily out of
service to be tested; this is especially true in the medical imaging department and the
laboratories.

Number of Devices Returning for Repair

Assume the standard to be: no return of equipment within six months of the last repair. Assume
the actual measurement was: 1 device was returned 3 times within 6 months. Possible corrective
measures are:
1. examine the record and identify past actions;
4.4. QUALITY ASSURANCE AND CQI 55
2. assess what type of intermittent problems could occur and test for these; and

3. ensure another audit is done within 1–3 months to make sure the problem is fixed.
There can be several reasons for this type of problem to occur. One reason can be that the
fault is intermittent and so it is difficult to see it when the CED tests it for a repair. Patience is
needed to repeat the testing many times to get to a point where the fault occurs.
Remembering one such case in a hospital in Moncton (NB), after such an audit, an elec-
troshock device in psychiatry was sent 3 times within 6 months with the note that it was not dis-
charging properly; the technologist had to repeat the test 25 times before identifying the problem,
which he did and repaired. The audit had allowed to search for such incidents in the computerized
equipment management system and find this particular problem.
Another reason for such incidences to occur can be due to a ‘finger problem’; that is, a user
error in using the equipment. User-training would be the solution in this case. Moreover, perhaps
simple instructions could be attached to the device for people who do not use it frequently.

Example of a Budget Audit

Assume the standard for the actual expenses of the CED to be within 5% of the approved operating
budget. If the actual expenses showed a 10% over expenditure, possible corrective measures are:
1. examine each budget category and expenditure;

2. assess whether this can be corrected or if the hospital needs to adjust the budget; this
may be for a case where more repairs and expensive parts were needed than in previous
years. Another reason may be that the staff level has not increased along with increased
acquisitions of medical devices and so the CED cannot perform all its functions and
activities as planned in the QA program. Therefore, the CED manager needs to apply
for a staff increase or re-allocate resources to a priorized workload and responsibilities.

Measuring the Satisfaction of Service

The last example is on measuring the satisfaction of service. There are various ways to measure this:
1. send a questionnaire to users in a number of departments, especially those which have a
substantial number of devices and who use the CED service more frequently;

2. record the number of complaints (verbal, written);

3. study deficiencies in the accreditation report if any were noted during the accreditation
review;
56 4. SAFETY CONSIDERATIONS, MINIMIZING LIABILITY, AND CQI
4. assess the average time lag between requests for service and delivery. Sometimes a CED
is waiting for a part which is delivered with some delay. A solution in this type of situ-
ation is to ensure the owner or user is aware of the reason for the delay. If a repair will
take longer than one or two days, then a note could be sent to the department who owns
the equipment.

REFERENCES
AAMI.org (n.d.). Available at: http://www.aami.org/publications/standards/60601.html; last ac-
cessed May 2013.
ANSI (n.d.). “American National Standards Institute.” Available at: www.ansi.org/; last accessed
July 2013.
Clemenhagen, CJ (1985). “Quality Assurance in the Hospital- Making it Work.” CMAJ, 133:
editorial.
CSA (n.d.). “Canadian Standards Association.” Available at: http://www.csa.ca/cm/ca/en/home;
last accessed July 2013.
EMC (n.d.). “Electromagnetic Compatibility.” Available at: http://www.medicalelectronicsdesign.
com/article/new-emc-requirements-updated-medical-devices-directive; last accessed
May 2013.
FDA (n.d.). “Food and Drug Administration.” Available at: www.fda.gov/; last accessed July 2013.
Hill, GN, Hill, KT (1981-2005). “Product Liability.” Available at: http://legal-dictionary.thefreed-
ictionary.com/Product+Liability; last accessed September 2013.
IEC (n.d.). “International Electrotechnical Commission.” Available at: www.iec.ch/; last accessed
July 2013.
Institute of Medicine (1985). Assessing Medical Technologies. National Academy Press. Washington,
D.C.
Keeton, P (1972). “Product Liability and the Meaning of Defect.” Available at: http://
heinonline.org/HOL/LandingPage?collection=journals&handle=hein.journals/stml-
j5&div=12&id=&page=; last accessed September 2013.
“Medical Device – Drug and Health Products." Available at: http://www.hc-sc.gc.ca/dhp-mps/
md-im/index-eng.php; last accessed July 2013.
NFPA (n.d.). “National Fire Protection Agency.” Available at: www.nfpa.org/; last accessed July
2013.
4. OTHER SUGGESTED READING 57
Roy, OZ (1980). “Summary of Cardiac Fibrillation Thresholds for 60 Hz Currants and Voltages
Applied Directly to the Heart.” Med. Biol. Eng. Comput. 18(5):657-659. DOI: 10.1007/
BF02443140.
UL (n.d.). “Underwriters’ Laboratory.” Available at: http://www.ul.com/global/eng/pages/; last
accessed July 2013.
Witters, D (2009). “Medical Devices and EMI: The FDA Perspective.” Available at: http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm106367.htm; last accessed July 2013.

Telemedicine: Applications and

Issues
This chapter begins with definitions of telemedicine, telehealth, and telecare, followed by a discus-
sion on drivers of this technology, benefits and limitations, examples of clinical applications, and a
brief description of the technology used.

5.1 DEFINITIONS
Telemedicine, in its broadest terms, is medicine delivered at a distance. In more recent terminology,
it is meant to represent the transfer of electronic medical data from one location to another. In 1995,
telemedicine was defined as the use of telecommunications to provide medical information and ser-
vices, and in 1999, telemedicine was said to utilize information and telecommunications technology
to transfer medical information for diagnosis, therapy, and education. The information can be in
the form of images (from pathology, dermatology, or from X-Ray, ultrasound, CT-Scans, MRI); it
can be a live video and audio conference between patients and physicians. Video and sound files,
patient medical records, and output data from medical devices can all be sent through modern
telecommunication networks. The transfer of information or data can be done in real-time or they
can be sent at a later time in a block. This can happen in the presence or absence of caregivers, and
with or without the presence of the patient (Norris, 2002).
Telehealth is defined as the use of information and communication technologies to transfer
health care information for the delivery of clinical, administrative, and educational services. Today,
psychologists and community workers are increasingly involved in patient care and some of this can
be done from a distance with telehealth.
Telecare utilizes information and communication technologies to transfer medical informa-
tion for the diagnosis and therapy of patients in their place of domicile. There is a slight difference
in the three definitions but overall, the principles remain the same: transmission from a distance,
whether it be from a hospital or a patient’s home, to a center for diagnosis and medical care (Norris,
2002).
60 5. TELEMEDICINE: APPLICATIONS AND ISSUES
5.2 DRIVERS OF THE TECHNOLOGY

5.2.1 TECHNOLOGICAL DRIVERS

Increased use of computers and of various forms of information technologies in medicine, and the
advent of broad network and telecommunication infrastructure in industrialized countries have led
to the development and use of telemedicine. Moreover, we live in a technology-led society so there
is no surprise to see an increased use of technology for several types of medical services, including
the implementation of electronic medical records and telemedicine, among others. The cost, power,
and reliability of the technology as well as the implementation of fiber optic networks with broad
bandwidth, even in remote and rural areas, have enabled the proliferation of the new technologies
and of telemedicine.

5.2.2 NON-TECHNOLOGICAL DRIVERS

Several factors influenced the development of telemedicine services: one major benefit for patients
is the access to specialized health services that do not exist in their geographical area; this prevents
them from having to drive long distances to access these services. This is particularly important in
rural and isolated communities. The weather can be a factor when it is responsible for an absence
of transportation that can last days or weeks, which is frequently the case in the Northern Com-
munities of Alaska, the Yukon, Labrador, Newfoundland, and others.
Penal and mental institutions can access health care without moving inmates, an important
consideration with the security that this entails in the case of dangerous or violent persons. Tele-
medicine is also of benefit for travellers on ships or airplanes who experience a medical emergency.
For example, British Airways (BA), which flew 30 million people between April 1993 and March
1994 experienced 2078 medical incidents on their flights. They had access 24 hours a day to a phy-
sician and could radio the symptoms and other medical data to the medical center in the U.K.. This
avoided many unscheduled diversions on long flights, which was of benefit to BA and its passengers
(Bagshaw, 1996). In 1999 and 2000, BA added ECG and oxygen monitors, respirators, and portable
defibrillators in all their long flight aircrafts. Similarly, at sea, ships can relay patient information
through radio links to a medical center which can again minimise diversions to ports not on the
schedule (Wootton, 1996).
Another source driving the development of telemedicine was in military applications, to
quickly triage casualties and to provide initial emergency treatment in the battlefield. The main
types of telemedicine used in military applications were teleradiology and telesurgery.

5.2.3 HOME TELECARE

Home telecare is another important driver of the technology. This arises from the need for patients
to download their data, especially in cases where they have a chronic disease such as diabetes. It is
5.3. MEDICAL APPLICATIONS OF TELEMEDICINE 61
also less costly to deliver services to the elderly in their home than to hospitalise them. The elderly
frequently have chronic health problems, so regular data transfer of vital signs, glucose, and other
data can help manage their health. It is easier for the elderly to be monitored at home or close to
where they live, than for them to travel long distances to receive specialized medical services. With
the aging population, this will become even more important. The same situation applies to persons
with disabilities who would benefit greatly by receiving medical services either in their home or
close by.
Another application of telemedicine is in disaster management. Gershnek and Burkle (1999)
argue that appropriate telemedicine applications can improve medicine outcomes in cases of disas-
ters; these can be based on previous experience learned from a decade of civilian and military disas-
ter (wide-area) telemedicine deployments. The authors review the history of telemedicine activities
in actual disasters and similar scenarios, as well as ongoing telemedicine innovations that may be
applicable to disaster situations. They recommend that emergency care providers plan effectively
to utilize disaster-specific telemedicine applications to improve future outcomes (Garshnek and
Burkle, 1999).
There are few studies about the cost-effectiveness of telemedicine services compared to
regular clinical services, but it is intuitive that telemedicine probably costs less than hiring health
professionals in areas where the population is sparse. Patients expect to have access to all medical
services they need in a timely fashion.
Other drivers would be market development by companies selling equipment, bandwidth, or
the telemedicine service itself. Health policy and strategy can also have a major impact on whether
the technology gets adopted and used.

5.3 MEDICAL APPLICATIONS OF TELEMEDICINE

Several medical specializations have benefitted from this approach. The most common uses of tele-
medicine in 1997, in descending order, were in radiology (50%), cardiology (just over 40%), ortho-
pedics (35%), dermatology (32%), and psychiatry (30%) (Congress report, 1997). Globally, in 2009,
in developed and developing countries, radiology remained the most common application with
60% of countries offering some teleradiology services, 33% of which were well established services.
In the same report, the global figure for telepathology and teledermatology was around 40% with
17% of services well established. For telepsychiatry, the numbers were 24% and 13% (WHO, 2010).
While telemedicine is being used primarily for specialist consultation and second opinions,
other applications gained ground such as: the management of chronic illness; emergency and triage;
surgical follow-up, diagnostic exam interpretation; and several home health care services. There are
also non-clinical uses such as distance learning, grand rounds for physicians, and administrative
meetings.
62 5. TELEMEDICINE: APPLICATIONS AND ISSUES
The American Telemedicine Association (ATA) published standards and guidelines that
are available at no cost on their website. These apply to several clinical applications such as mental
health, teledermatology, diabetic retinopathy, telerehabilitation, telepathology, home care telehealth;
new guidelines are also under development (ATA, 2012).
Now we look more closely at examples of telemedicine in a variety of clinical services. In
tele-consultation, a patient is examined and interviewed at a distance. This can be in the presence of
a local physician, nurse practitioner, or a nurse, and is usually to consult a specialist in a larger center
where these do not exist in the region where the patient lives. Aside from providing access to spe-
cialists, another result is the enhanced training and education of the physician or nurse in a remote
location. Several factors can optimize consultations done by telemedicine. Both sides should agree
on the purpose of the consultation, whether it is for making a diagnosis, monitoring the progress
of treatment, or to develop the skills of health workers. Both teams should establish the process to
be followed and the content of the session and avoid distractions; technology adjustments may be
necessary during the consultation, so it is good planning to have a technician accessible nearby to
help in these situations, ensuring no time is wasted and that the entire session proceeds smoothly.
There should also be some training so that the team using the equipment is familiar with its op-
eration. The delegation of clinical responsibility needs to be formalized and decisions made on the
documentation that will be needed.

5.3.1 EXAMPLES OF MEDICAL APPLICATIONS OF TELEMEDICINE

Tele-Radiology

Tele-radiology is one of the most commonly used applications of telemedicine. In 2006, 67% of
radiology practices in North America used telemedicine (Steinbrook, 2007). Tele-radiology consists
of the transfer of images captured by X-Ray equipment, CT-Scanners, and MRI and Ultrasound
equipment. This can be done in real-time (synchronous mode) or in batches (asynchronous mode).
Transmissions are usually from a remote location to a larger center, to enable the images to be read
and interpreted by radiologists. The approach is also useful for training new radiologists, assisting
radiologists in developing countries, diagnosing injured soldiers near or on the battlefield, and per-
forming radiological procedures in space. The images are first digitized, compressed, and sent over
a communication network with a fast speed modem; after decompression at the receiving end, the
image can be enhanced by magnification, image rotation, or edge enhancement. Care must be taken
that the quality of the image does not degrade at each transmission step.
5.3. MEDICAL APPLICATIONS OF TELEMEDICINE 63
Tele-Surgery

Tele-surgery consists of surgery performed at a distance. It was first developed for military appli-
cations, but soon after was applied to civilian situations. The first documented civilian tele-surgery
was a gall bladder removal in 2001 between Strasbourg, France, and New York City, a distance of
7000 km (Larkin, 2001). Since then there have been several examples of tele-surgery, such as gall
bladder and prostate gland removal, cardiac, thoracic, and urologic surgery. This is usually done
with robotic surgery equipment at both ends, with the manipulations from the principal surgeon
replicated at the patient location.

Tele-Psychiatry

Tele-psychiatry is where the psychiatrist and the patient meet over teleconference facilities. This
approach can be used for the assessment and diagnosis or a variety of mental illnesses, treatment
consultations, case conferencing and management, education and supervision, support, forensic
and legal assessments, administration and data transfer, research, and psychological testing, among
others. Tele-psychiatry has not been shown to be effective in the diagnosis of schizophrenia and
is not recommended when dealing with violent or agitated patients. In 2010, in the Province of
Ontario, 24 centers were connected to 1 of 3 centers offering tele-psychiatry services for children
and youth (MCYS, n.d.). In the U.S., several articles were published in 2013 on tele-psychiatry,
which indicates that this practice is still in use and developing (Fortney et al., 2013; Shore, 2013).

Tele-Pathology

Tele-pathology refers to pathology services carried out over a distance. For example, images of
tissue captured by a microscope can be transferred to a center where a pathologist can identify if
the cells are cancerous or not. This principle is similar to what is used in tele-dermatology where
skin rashes or lesions are photographed and sent to a specialist for a diagnosis or for a second
opinion. This also includes automated melanoma diagnosis (Wootton and Oakley, 2002). There are
also applications in the field of cardiology, obstetrics, pediatric medicine, and many others. There
were some interesting telemedicine projects in the U.S. such as the sex assault of children project
(available at: http://www.utexas.edu/research/tipi/research/CJA.pdf ), Nearly one-fifth of all clin-
ical activity in the U.S. can be attributed to prison telemedicine. Globally, an application that is
becoming increasingly important regards the response to disasters.

Tele-Education

Tele-education consists of sessions called grand rounds where patient cases are discussed or presen-
tations are made on new procedures or new treatments. In large cities like New York and London
64 5. TELEMEDICINE: APPLICATIONS AND ISSUES
it would make sense to provide continuing education sessions for physicians and interns who work
in several medical centers from a single location, as this would save substantial time driving from
one place to the other. As mentioned previously, clinical education can also happen during tele-con-
sultation or via the Internet. Public education on preventive medicine and healthy lifestyles can be
done through the Internet.

5.4 REPORT TO THE U.S. CONGRESS (1997)

In January 1997, a report on telemedicine was submitted to the U.S. Congress. This included some
definitions and the process of evaluation of these types of services. It discussed legal issues such as
licensure of physicians offering the services, remuneration issues, safety and standards, telecommu-
nications infrastructure needed to set-up the services, as well as issues concerning privacy, security,
and confidentiality. The Federal Evaluation Framework described in the 1997 Report to Congress
recommended that evaluations of telemedicine include a description on whether the clinical out-
comes were acceptable; the technical acceptability by patients to be assessed at a distance through
technology, and by providers using the technology; and the level of integration with the health
systems interface. A cost vs. benefits analysis needs to be addressed as well as whether telemedicine
can improve access to health care services (Report to Congress, 1997).

5.5 EVALUATION ELEMENTS FOR CLINICAL TELEMEDICINE

When performing an evaluation of a clinical telemedicine service, several elements need to be
considered: Do the strategic objectives meet the sponsor’s purposes? Regarding the clinical objec-
tives, the evaluation should consider whether the effects intended on the quality of health care, its
accessibility and cost meet the expectations. Is the business and project management plan sustain-
able? There should be a detailed work plan, a schedule, and a realistic budget. The evaluation would
normally compare conventional versus telemedicine for specific clinical services to be delivered; the
evaluation would assess the technical, clinical, and administrative processes. It should have measur-
able outcomes and proper documentation.

5.6 THE REPORT ON U.S. TELEMEDICINE ACTIVITY BY THE

ASSOCIATION OF TELEMEDICINE SERVICE PROVIDERS
(ATSP) IN 1998
The report from the ATSP mentioned that 46 states in the U.S. had some telemedicine services,
with California, New York, Texas, and North Carolina being the largest users. The most common
use was for consultations and second opinions; second most common was the follow-up of chronic
diseases and surgery. There were 41,000 consultations in 1997 and many more were expected in the
future. More than 45 specialties using some form of telemedicine were inventoried. A more recent
5.7. REPORT TO THE U.S. CONGRESS (2001) 65
report, Telemedicine Reimbursement Report of 2003, can be seen at: http://www.hrsa.gov/ruralhealth/
about/telehealth/reimburse.pdf.
An important question remains: Is telemedicine cost-effective? Few studies have yet to
answer this question. A literature review of 612 studies revealed in 2002 that only 55 had some
form of report on cost-benefit analysis; of the 24 retained for a more comprehensive study, none
had included all the criteria judged essential for economic analyses (Whitten et al., 2002). In the
year 2000, one review concluded that real-time tele-dermatology was comparable to conventional
services; no difference was found in cost effectiveness (Wootton, 2000). But in 2010, Whited
published an article on the economic analysis of tele-dermatology and concluded that it was cost
effective compared to conventional dermatology services, especially when used in the store-forward
mode, an asynchronous model (Whited, 2010).

5.7 REPORT TO THE U.S. CONGRESS (2001)

The report provided an update on telemedicine services in the U.S. and discussed issues such as the
lack of reimbursement, legal issues, safety and standards, as well as privacy, security, and confiden-
tiality (Report to Congress, 2001).

5.7.1 BARRIERS AND ISSUES CONCERNING THE IMPLEMENTATION

AND USE OF TELEMEDICINE
The list includes but is not limited to the following. Many public and private payees and insurers do
not cover telemedicine services; lawyers see the potential for malpractice suits; telemedicine could
open the door to out-of-state or out-of-province quacks; people worry about privacy and confi-
dentiality; telemedicine visits must be planned around the physician’s and technician’s schedule; the
possibility of a disclosure of information to partners of patients, in the case of HIV for example.
Paul et al. (1999) reported that end-user and technical training were major barriers, but did
not support the quality of the video system reliability, or the perceived inconvenience for phy-
sicians to use the equipment as barriers to telemedicine. They argued that a mismatch between
the sophistication of the technology and end-user requirements for clinical activities and patient
confidentiality and privacy issues were supported as barriers, but how these impacted telemedicine
utilization was different than what they had expected. Unsatisfactory sound quality of the telemedi-
cine equipment was identified as a frequent and unexpected barrier to telemedicine utilization rates
(Paul et al., 1999).
No doubt there can be substantial benefits to the use of telemedicine: better access to health
care with access to specialists not available where they live and a faster diagnosis; improved com-
munication between care-givers; easier continuing education; better access to health information;
potentially reduced costs, especially for the patients who would have travel costs, nights away from
home, and perhaps need for baby sitting or elderly care help; and reduced time away from work.
66 5. TELEMEDICINE: APPLICATIONS AND ISSUES
There are limitations such as: a lower patient-physician relationship than there is with a
face-to-face consultation; the technology is impersonal; or the schedule for fitting in telemedicine
may disrupt the organizational workflow. Additional training is needed and protocols need to be
developed; there may be an uncertain quality of the health information transmitted and a low rate
of utilization which makes the service uneconomical. Another concern is the delay in signal trans-
mission, which is critical in cases of tele-surgery; the guideline requires the delay to be 300 ms or
less. This can be a challenge for long distances such as transatlantic transmissions.
Specific issues are: (1) physicians may need a license for each jurisdiction in which they wish
to practice; (2) issues of liability—who is responsible for the service, the physician at the distant end
or the personnel at the patient end?; (3) many physicians view this as a threat of competition, with
services from elsewhere competing with their own; (4) physicians need to plan time for telemedi-
cine consultations or for interpreting the information sent to them between their other duties; and
some states are blocking interstate telemedicine in their jurisdiction. There are also questions such
as: Do you need a physician at either end? A nurse? A technical expert to operate the equipment?
There are several benefits for physicians: (1) they can attend medical education sessions
without having to travel, where this service exists; (2) they can consult a specialist to confirm a pa-
tient’s condition when this specialization is not available in their geographical area; and (3) they can
themselves get referrals if they offer a service that is not available in other places. Some examples
in Canada are the following:
• The Hospital for Sick Children in Toronto opened a telemedicine clinic with Thunder
Bay and with four other health regions in Northern Ontario.

• The University of Ottawa Heart Institute offers telemedicine cardiac care to a hospital
in the small town of Pembrooke (Ontario).

• Parry Sound and six smaller centers receive tele-psychiatry services from Toronto.

• The oldest telemedicine service in Canada (1977) began with Memorial University and
its Health Sciences Centre in St-John’s, offering telemedicine services to several remote
parts of Newfoundland.

• St-John Regional Hospital in New Brunswick interprets X-Ray images sent from
Grand Manan Island (NB), thus reducing expensive and long trips from the island to
the mainland.

5.8 ETHICAL AND LEGAL ASPECTS

All countries and states using telemedicine need to develop policies that affect access, delivery,
reimbursement, licensure of users, maintenance of confidentiality and privacy. The policies must
5. REFERENCES 67
clarify what rights of access patients in a certain jurisdiction will have. This of course depends on the
level and quality of services offered. There must be policies to ensure the protection of data gathered
by the means of telemedicine. The expected duty of care and standard of care should be the same
as what is expected from a conventional clinical visit. Physicians are as vulnerable to malpractice
suits, whether they see patients in their office or via telemedicine. The suitability of the equipment
in transmitting an acceptable level of quality of images and data is important. A process must be
in place in case of failure of the equipment; perhaps back-up equipment would be made available
or the patient re-scheduled, or if more urgent, then the patient may be referred to another center
that can offer the service.
Physicians must be licensed for the various jurisdictions where they will offer their services
by telemedicine. The facility must be accredited and a schedule established for the re-imbursement
of the services. Intellectual property rights must be clearly identified as telemedicine involves more
than one center and team. Finally, it is critical to ensure the confidentiality, privacy, and security of
patients and their data. For example, it may not be clear to the patient, who is in a room at one end,
who is present at the other end, whether seen by the camera or not; everyone in the room must be
identified.

5.9 TECHNICAL REQUIREMENTS

T1 lines that transmit at a speed of 1.54 Mbps would support imaging modalities. Multiplexing
can be used to fractionate a T1 line for use in television and to transmit medical images at the
same time. Interactive video is a useful modality for consultations. Leased ISDN telephone lines
(Integrated Services Digital Network) have twice the capacity of regular lines. High speed fiber
optic lines are excellent for maintaining the quality and speed of transmission.

REFERENCES
ATA (2012). “The American Telemedicine Association.” Available at: http://www.american-
telemed.org/practice; last visited July 2013.
Bagshaw, M (1996). “Telemedicine in British Airways.” J. Telemed Telecare, 2 (suppl): 36-38.
Choi, YB, Krause, JS, Seo, H, Capitan, KE, Chung, K (2006). “Telemedicine in the USA: Standard-
ization through Information Management and Technical Applications.” IEEE Comm.
Mag. April: vol 44(4): 41-48. DOI:10.1109/MCOM.2006.1632648.
Fortney, JC, Pyne, JM, Mouden, SB, Mittal, D, Hudson, TJ, Schroeder, GW, et al. (2013). “Prac-
tice-Based Versus Telemedicine-Based Collaborative Care for Depression in Rural Fed-
erally Qualified Health Centers: A Pragmatic Randomized Comparative Effectiveness
Trial.” Amer. J. Psychiat. April, 4(170): 414-425. DOI:10.1176/appi.ajp.2012.12050696.
68 5. TELEMEDICINE: APPLICATIONS AND ISSUES
Garshnek, V, Burkle, FM (1999). “Telemedicine and Telecommunications to Disaster Medicine
Historical and Future Perspectives.” J. Am. Med. Inform. Assoc. ( JAMIA) Jan-Feb, 6(1):
26–37.
Larkin, M (2001). “Transatlantic, Robot-Assisted Telesurgery Deemed a Success.” Lancet, 358
(9287): 1074.
MCYS (n.d.). “Ministry of Children & Youth Services.” Available at: http://www.children.gov.
on.ca/htdocs/English/news/factsheets/05102007.aspx; last accessed July 2013. DOI:
10.1016/S0140-6736(01)06240-7.
Paul, DL, Pearlson, KL, McDaniel, Jr. RR (1999). “Assessing Technological Barriers to Telemed-
icine:Technology-Management Implications.” IEEE Trans. Eng. Manag., Aug., 46 (3):
279-288.
Report to Congress (1997). Available at: http://www.ntia.doc.gov/legacy/reports/telemed/index.
htm; last accessed July 2013. [This report also contains the 1996 report from the Institute
of Medicine on Telemedicine.]
Report to U.S. Congress (2001). Available by request at: http://ask.hrsa.gov/detail_materials.
cfm?ProdID=402; last accessed July 2013.
Shore, JH (2013). “Telepsychiatry: Videoconferencing in the Delivery of Psychiatric Care.” Amer. J.
Psychiat., March, 3(170): 256-262.
Steinbrook, R (2007). “The Age of Teleradiology.” New Engl. J. Med., 357:5-7. DOI: 10.1056/
NEJMp078059.
Whitten, PS, Mair, FS, Haycox, A, May, CR, Williams, TL, Hellmich, S (2002). “Systematic
Review of Cost Effectiveness Studies of Telemedicine Interventions.” BMJ. June 15,
324(7351): 1434–1437.
Whited, JD (2010). “Economic Analysis of Telemedicine and the Teledermatology Paradigm.”
Telemed e-Health, March, 16(2): 223-228.
Wooton, R (1996). “Telemedicine—A Cautious Welcome.” BMJ 313:1375-1377.
Wootton, R, Bloomer, SE, Corbett, R, Eedy, DJ, Hicks, N, Lotery, HE, et al. (2000). “Multicentre
Randomised Control Trial Comparing Real Time Teledermatology with Conven-
tional Outpatient Dermatological Care: Societal Cost-Benefit Analysis.” BMJ. May 6;
320(7244): 1252–1256.
Wootton, R, Oakley, A (2002). Teledermatology. RMS Press.
5. OTHER SUGGESTED READING 69
World Health Organization, (2010). “Telemedicine: Opportunities and Developments in Member
States. Report on the Second Global Survey on e-health.” Available at: http://www.who.
int/goe/publications/goe_telemedicine_2010.pdf; last accessed July 2013.

Impact of Technology on Health Care

and the Technology Assessment Process

6.1 IMPACT OF TECHNOLOGY ON HEALTH CARE

Chaudry et al. (2006) did a systematic review of the impact of health information technologies (IT)
on the quality, efficiency, and cost of medical care; 25% of the information came from four institu-
tions which had implemented internally developed systems, most of which were related to decision
support and electronic health records. The authors concluded that, for these four institutions, the
quality and efficiency of medical care were increased, but it was unclear whether cost was impacted
and whether the results could apply to other institutions. Of 257 studies the authors reviewed, the
primary domain of improvement was in preventive health. These authors found three benefits that
were considered as a positive impact: an increased adherence to guideline-based care; enhanced
surveillance and monitoring; and a decrease in medication errors. In terms of increased efficiency,
they found that there was a decrease in the utilization of care, but the time used in providing care
showed mixed results. The availability of empirical cost data was limited (Chaudry et al., 2006).
There was an increased use of technology for diagnosis, therapy, and monitoring during the
last two decades of the 20th century and the complexity of the devices increased over this time
period. The development of the Internet had an impact on the amount of information available to
health care personnel, but has led to information overload. However, there are both positive and
negative aspects to a greater connectivity. On the negative side, too much information can create
confusion, distraction, and even errors. On the positive side, the Internet provides access to journals
and medical information quickly, enabling caregivers to keep up to date. Consultations for a second
opinion or for an expert opinion are faster and more efficient. Some Decision-Support Systems
(DSS) can digest some of the information and provide knowledge that can help health care workers
make better and faster decisions in fast-paced environments. (See Part II for a discussion on the
impact of technology on the reduction of medical errors.) It is important to take into consideration
that an increased use of technology to sustain life also raises the issue of the quality of life, an ethical
question.
There is an economic aspect to this discussion. Expenditures on health care have been in-
creasing at high rates in the past two decades. For example, in the U.S., health care expenditures
were 13.5% of GDP in 1997, at a time when other western nations were at 10% (Germany, France,
and Switzerland). Total U.S. health expenditures rose from $888 billion in 1993 to $1,425 billion
72 6. IMPACT OF TECHNOLOGY ON HEALTHCARE
in 2001; it grew to 2.6 trillion in 2012. The health expenditure per capita was $8232.90 in 2012,
which was twice the OECD average. In Canada, the health expenditure per capita was $4607.80
in the same year. It is not simple to determine the impact of technology on health care costs. Tech-
nology has been expensive to acquire, but it also has had some impact on the reduction of costs. It
is perhaps more important to focus on ways that the acquisition of technology has changed the way
health care is delivered and received.
Some benefits of medical technologies are: Most technologies today have some form of au-
tomation which can save time for caregivers who can then spend more of their time on direct care
to patients. Another benefit is that patients have more ways to keep aware of their chronic health
conditions with home monitoring, or downloading data to heath care centers; thus, they may adhere
to lifestyles and medication regimens that could delay the progression of the disease. It is not dif-
ficult to imagine that, without this information, patients would have had multiple hospitalizations
in past eras each time their condition worsened. The reduced use of hospital beds by these patients
likely represents a major cost reduction for health care. Technology has, in many cases, enabled
caregivers to make an earlier diagnosis and thus begin therapy at early stages of a disease, which
would have some impact on outcomes and on the quality of health care. Colás et al. (2010) made
this point for one of the most expensive chronic condition: cardiac insufficiency or heart failure.
These authors argue that using implantable devices to stabilize their condition, and performing
the regular follow-up by telemedicine, provides major savings to the health care system in terms of
physician time, hospital capacity, and transportation costs for the patient. On the impact of health
information technologies on chronic care management, Marchibroda (2008) wrote:
The introduction of health IT, including electronic health records and health information
exchange, holds great promise for addressing many of the barriers to effective chronic
care management, by providing important clinical information about the patient when
it is needed, and where it is needed, in a timely, secure fashion. Having information from
the care delivery process readily available through health IT and health information
exchange at the national, state, and local levels supports key components of the chronic
care management process, including those related to measurement, clinical decision
support, collaboration and coordination, and consumer activation (Marchibroda, 2008).
A U.S. report by the National Center for Health Statistics (NCHS) shows, among many
other variables, the actual amount invested in durable medical equipment between 1960 and 2009,
and the proportion that this cost represents of the total health expenditures in the US. In 1960, 0.7
billion dollars were spent on medical equipment (2.6% of the total health expenditures). Although
the actual amount in dollars increased each year, reaching 34.9 billion in 2009, the proportion of
the equipment acquired over the total expenditures decreased over the years to reach a low value of
1.4% in 2009, the last year for which this data is available (NCHS, 2011).
6.2. THE HEALTH TECHNOLOGY ASSESSMENT PROCESS 73
However, the complexity of medical equipment continues to grow, and so is the dispro-
portionate relationship between initial cost and on-going support costs; the latter is expected to
continue to increase in the years to come. Design innovation, especially with regards to autonomic
systems, will require careful management. Clinical engineers can play a major role, not only in the
management of the technology, but they may also be able to influence some of the designs.

6.2 THE HEALTH TECHNOLOGY ASSESSMENT PROCESS

Since the middle of the twentieth century, medical equipment has become an essential part of the
provision of health care services in industrialized countries and even in many developing countries.
With the proliferation of medical devices flooding the market, and the spiraling increase of health
care expenditures, hospitals and other health care facilities have to make informed decisions on the
acquisition of new technologies. To help them in this process, several nations have created health
technology assessment (HTA) centers.
In addition to these HTA centers, there are groups of clinical and biomedical engineers and
not-for-profit organizations performing the evaluation of medical devices; these groups compare
different brands and various designs which perform a similar medical function. Important questions
are: What devices should be tested, and when? What tests are needed? Who should do the testing?
An effective approach is to test the devices in a human factors engineering laboratory which can
simulate the real environment and not only test the devices themselves but also the interaction of
users with the equipment (Easty et al., 2009). For example, Chan et al. (2011) evaluated the task
efficiency, usability, and safety of three order set formats: their hospital's planned CPOE (Com-
puterized Physician Order Entry) order sets, computer order sets based on user-centered design
principles, and existing pre-printed paper order sets. The participants were 27 physicians, residents,
and medical students. The measures were completion time (efficiency), requests for assistance (us-
ability), and errors in the submitted orders (safety). The User-Centered Design format was more
efficient and usable than the CPOE test format, even though training was provided for the latter.
The authors concluded that application of user-centered design principles can enhance task effi-
ciency and usability, thus increase the likelihood of successful implementation (Chan et al., 2011).
This example shows how this type of testing can be effective in selecting the best technologies for
specific functions and their potential users.
In addition to the existence of national and regional organizations in many countries that
provide medical technology assessments, there are also international agencies supporting the
advancement of HTA on the global stage such as Health Technology Assessment international
(HTAi) and the International Network of Agencies in Health Technology Assessment (INAHTA).
74 6. IMPACT OF TECHNOLOGY ON HEALTHCARE
6.2.1 WHAT IS A HEALTH TECHNOLOGY ASSESSMENT (HTA)?
Technology assessment originated in the 1960s and was meant principally to instruct policy-mak-
ing by governments on health technology investments. Goodman provides a definition of TA from
an Institute of Medicine Publication in 1985:
We shall use the term assessment of a medical technology to denote any process of
examining and reporting properties of a medical technology used in health care, such as
safety, efficacy, feasibility, and indications for use, cost, and cost-effectiveness, as well as
social, economic, and ethical consequences, whether intended or unintended (Goodman
2004, in Institute of Medicine, 1985).
Other definitions are listed in Goodman (2004): “Technology assessment is a form of policy
research that examines short- and long-term social consequences (societal, economic, ethical, and
legal) of the application of technology.” For his part, Banta (1993) wrote: “The goal of technology
assessment is to provide policy-makers with information on policy alternatives” (Banta, 1993).
The U.K. National Health Service R&D Health Technology Assessment Programme (2003)
defines HTA:
Health technology assessment considers the effectiveness, appropriateness and cost of
technologies. It does this by asking four fundamental questions: Does the technology
work, for whom, at what cost, and how does it compare with alternatives?
The U.S. Congress Office of Technology Assessment (1994) provided the following defi-
nition: “Health technology assessment ... is a structured analysis of a health technology, a set of
related technologies, or a technology-related issue that is performed for the purpose of providing
input to a policy decision.”
In Canada, the Canadian Agency for Drugs and Technology Assessment (CADTH) writes:
“Decisions about which medical devices and drugs to use are crucial to the quality and sustainability
of health care in Canada. Access to evidence-based information is key to making informed deci-
sions that harness the benefits of technology while getting the best value from every health dollar.
CADTH provides decision-makers with the evidence, analysis, advice, and recommendations they
require to make informed decisions in health care.”
The International Network of Agencies for Health Technology Assessment (INAHTA)
writes: “Health technology assessment (HTA) is the systematic evaluation of properties, effects,
and/or impacts of health care technology. It may address the direct, intended consequences of
technologies as well as their indirect, unintended consequences. Its main purpose is to inform tech-
nology-related policymaking in health care. HTA is conducted by interdisciplinary groups using
explicit analytical frameworks drawing from a variety of methods. In addition to HTA being used
for informing governments on health policy, it is also very useful for health care facilities planning
6.2. THE HEALTH TECHNOLOGY ASSESSMENT PROCESS 75
to invest substantial funds into new technologies. It is prudent for these health care institutions to
find out as much as they can about the new technology they are thinking of acquiring.
A technology assessment consists of several aspects: technical, economic, medical effective-
ness, and safety. The usual approach is to compare the various ways of accomplishing a clinical
function. Take, for example, the measurement of blood glucose in the home environment. The
following alternatives exist:
1. small glucose monitors where patients prick their finger, place the blood on a strip,
which is then read by a monitor;

2. there is a watch that patients can wear to get a continuous reading of their glucose level.
Advantages and disadvantages of each approach, their accuracy, the total capital cost and
the cost per test should be compiled; and

3. finally, the life cycle of the device and the safety for patients and staff need to be con-
sidered.
HTA centers usually separate the work they do into two types of assessments: drugs and
technologies. In Canada, the national HTA is called “Canadian Agency for Drugs and Technolo-
gies in Health”; in the U.S., the Office for Technology Assessment (OTA), which published over
750 studies, was closed in 1995. However, there is a strong voice for re-funding this type of orga-
nization; Sadowski (2012) wrote: “there has been vocal support by many prominent scholars and
politicians to either re-fund it or establish a similar method of technology assessment."
There is a difference between evaluation and assessment. ECRI has over many years provided
evaluations of a variety of medical devices. For example, they can provide a comparison of a number
of electrosurgical generators. This would be similar to the Consumer Reports comparing trucks,
cars, etc. An assessment as carried out by HTA centers would look at different manners of per-
forming a clinical function rather than comparing similar equipment from different manufacturers
as described in the example below for kidney stone removal.
In this example of a medical technology assessment, it is appropriate to compare various ways
to remove kidney stones:
1. a traditional surgery;

2. a catheter introduced though the urethra to the kidney and ultrasound signal to blast
the stones; and

3. a newer approach called lithotripsy; in this case, there are at least three different types
of technologies to accomplish the task. Conventional surgery requires several days of
hospitalization and the risk for an infection is high.
76 6. IMPACT OF TECHNOLOGY ON HEALTHCARE
The ultrasound approach is common, but sometimes the stones are located in pockets not
reachable or visible by this method. Lithotripsy does not require hospitalization and is non-invasive,
as the wave generated to blow up the stone is applied though the skin. This equipment is quite
expensive and is likely justified for a health care facility serving a population of a million people or
more. Detailed costs per procedure need to be identified. Serviceability is another aspect to consider.
Types of organizations that carry-out HTAs are numerous: regulatory agencies, government
and private sector payers, managed care organizations, health professions organizations, standards
setting organizations, hospitals and health care networks, group purchasing organizations, patient
and consumer organizations, government policy research agencies, private sector assessment/policy
research organizations, academic health centers, biomedical research agencies, health product com-
panies, venture capital groups, and other investors (Goodman 2004).
A framework for HTA was offered by the European Collaboration for Health Technology
Assessment (Busse, 2002, in Goodman, 2004) where the following steps are usually followed: the
process begins with a submission of an assessment request or an identification of an assessment
need; a prioritization is done as to which HTAs are more urgent; the work is commissioned by
selecting the proper group to carry-out the HTA.
An assessment follows these steps:
• Definition of the policy question(s);

• Elaboration of the HTA protocol;

• Collecting background information and determination of the status of the technology

• Definition of the research questions;

• Sources of data, appraisal of evidence, and synthesis of evidence for each of safety, ef-
ficacy/effectiveness, psychological, social, ethical, organizational, professional, economic
considerations.
A draft is written on the discussions, conclusions, and recommendations, followed by an ex-
ternal review, and publishing of the final HTA report with an executive summary of the report. The
next step is dissemination of the report. Later on, there may be an update needed of this particular
HTA. Several countries follow a similar process for their HTAs.
In conclusion, there are several centers performing HTAs around the world, so a literature
review prior to planning a new HTA is essential. Perhaps HTAs that have been done are now
obsolete and in need of a review or update, or an HTA may be more appropriate for a particular
environment than another. In general, HTAs are useful and can save much effort and/or a waste of
investment for future acquisitions of medical technologies.
6.REFERENCES 77
REFERENCES
Banta, HD, Luce, BR (1993). Health Care Technology and Its Assessment: An International Perspective.
New York, NY: Oxford University Press.
Busse, R, Orvain, J, Velasco, M, et al. (2002). “Best practice in undertaking and reporting health
technology assessments.” Int. J. Technol. Assess. Health Care, 18: 361-422. DOI: 10.1017/
S0266462302000284.
Canadian Agency for Drugs and Technology Assessment (CADTH). Funded by Canada’s fed-
eral, provincial, and territorial governments, CADTH is an independent, not-for-profit
agency that delivers timely, evidence-based information to health care leaders about the
effectiveness and efficiency of health technologies. http://www.cadth.ca/en/cadth.
Chan, J, Shojania, KG, Easty, AC, Etchells, EE (2011). “Does User-Centred Design Affect the
Efficiency, Usability, and Safety of CPOE Order Sets?” J.A.M.I.A. May, 18(3): 276-281.
DOI: 10.1136/amiajnl2010000026.
Chaudhry, B, Wang, J, Wu, S, Maglione, M, Mojica, W, Roth, E, et al. (2006). “Systematic Re-
view: Impact of Health Information Technology on Quality, Efficiency, and Costs of
Medical Care.” Ann. Intern. Med. 144: E-12-E-22. DOI: 10.7326/0003-4819-144-10-
200605160-00125.
Colás, J, Guillén, A, Moreno, R (2010). “Innovation in Health Care technology: Is it part of the
problem or part of the solution? eHealth gives the answer.” Proc. IEEE/EMBS Conf.
Aug.-Sept. : 1057-1060. DOI: 10.1109/IEMBS.2010.5627640.
Easty, A. C., Cafazzo, J. A., Chagpar, A (2009). “Improving Safety in Healthcare through the Es-
tablishment of a Healthcare Human Factors Team.” In World Congress on Medical Physics
and Biomedical Engineering, September 7-12, Munich, Germany, Springer Berlin Heidel-
berg: 324-327. DOI: 10.1007/9783642038853_90.
Goodman, CS (2004). “HTA 101: Introduction to Health Technology Assessment.” Available at:
http://www.nlm.nih.gov/nichsr/hta101/ta101_c1.html; last visited in May 2013.
Institute of Medicine (1985). Assessing Medical Technologies. National Academy Press. Washington,
D.C.
International Network of Agencies for Health Technology Assessment (INAHTA) . http://www.
inahta.org/GO-DIRECT-TO/Members/
Marchibroda, JM (2008). “The Impact of Health Information Technology on Collaborative
Chronic Care Management.” J. Managed Care Pharm. Suppl., March, 14(2): S3-S11.
78 6. IMPACT OF TECHNOLOGY ON HEALTHCARE
NCHS (2011). “Table 128." Available at: http://www.ncbi.nlm.nih.gov/books/NBK98779/table/
trendtables.t128; last accessed July 2013.
Sadowski, J (2012). “Non-Partisan Advice Needed by Congress.” The Atlantic. October 26. Available
at: www.ota.fas.org; last accessed September 2013.
“U.K. National Health Service R&D Health Technology Assessment Programme" (2003). Avail-
able at: http://www.ncchta.org/about/index.shtml; last accessed June 1, 2003.
U.S. Congress, Office of Technology Assessment (1994). “Protecting Privacy in Computerized
Medical Information.” U.S. Government Printing Office. Washington, D.C.
World Health Organization,(n.d.). “Technology Assessment.” Available at: http://www.who.int/
medical_devices/assessment/en/; last accessed September 2013.
79

Author Biography
Monique Frize is a Distinguished Professor at Carleton
and Professor Emerita at University of Ottawa. For 18 years
(1971-1989) she was a hospital biomedical engineer and has
been a professor in electrical and biomedical engineering
since 1989. Monique Frize has published over 200 journal
and conference proceedings papers on artificial intelligence in
medicine, infrared imaging, ethics, and women in engineering
and science. She is a Fellow of IEEE (2012), the Canadian
Academy of Engineering (1992), Engineers Canada (2010),
Officer of the Order of Canada (1993), and recipient of the
2010 Gold Medal from Professional Engineers Ontario and
the Ontario Society of Professional Engineers. She has re-
ceived five honorary doctorates in Canadian universities since
1992. Her book, The Bold and the Brave: A History of Women in
Science and Engineering was released by the University of Ottawa Press in November 2009; Ethics
for Bioengineers was published by Morgan & Claypool (2011); and her new book, Laura Bassi and
Science in 18th Century Europe: The Extraordinary Life and Role of Italy’s Pioneering Female Professor,
was released by Springer in July 2013.

RA - Use of Gondola
No ratings yet
RA - Use of Gondola
3 pages
1266 - Teleradiology (2008)
No ratings yet
1266 - Teleradiology (2008)
301 pages
صيانة الاجهزة والمعدات الطبية
100% (1)
صيانة الاجهزة والمعدات الطبية
83 pages
Electrical Safety Book PDF
100% (2)
Electrical Safety Book PDF
36 pages
Aweer Power Station H' Phase IV
No ratings yet
Aweer Power Station H' Phase IV
117 pages
Medical Equipment Management Plan
100% (3)
Medical Equipment Management Plan
32 pages
Table For Medical Equipment Plan - Outline
0% (1)
Table For Medical Equipment Plan - Outline
2 pages
1 - Introduction To BME
100% (1)
1 - Introduction To BME
13 pages
SB-15 Operation Manual
100% (1)
SB-15 Operation Manual
223 pages
Biomedical Engineering Technology
100% (1)
Biomedical Engineering Technology
36 pages
Ipc2012 90459
No ratings yet
Ipc2012 90459
14 pages
Lecture 4 Effective Stress
86% (7)
Lecture 4 Effective Stress
18 pages
Service Manual Cobija Termica 6000 Medtronic # 8 (Capitulo Mantenimiento Ingles)
No ratings yet
Service Manual Cobija Termica 6000 Medtronic # 8 (Capitulo Mantenimiento Ingles)
60 pages
Spesifikasi Philips Azurion 7 M20 FlexArm With IntraSight
No ratings yet
Spesifikasi Philips Azurion 7 M20 FlexArm With IntraSight
4 pages
Mindray Beneheart - r3
No ratings yet
Mindray Beneheart - r3
90 pages
Biomedical Engineering 20230808100923
No ratings yet
Biomedical Engineering 20230808100923
12 pages
Clinical Engineering Certification Study Guide
100% (1)
Clinical Engineering Certification Study Guide
170 pages
2018 Book BiomedicalEngineeringSystemsAn
No ratings yet
2018 Book BiomedicalEngineeringSystemsAn
418 pages
Dishwashing Liquid Is A Detergent Used To Assist in Dishwashing
No ratings yet
Dishwashing Liquid Is A Detergent Used To Assist in Dishwashing
3 pages
Wall Mounted CHW FCU Catalogue
No ratings yet
Wall Mounted CHW FCU Catalogue
48 pages
Manual Instalacao Eng d700
No ratings yet
Manual Instalacao Eng d700
16 pages
2 Marks Special Machines.
No ratings yet
2 Marks Special Machines.
26 pages
Medical Equipment Management Plan
No ratings yet
Medical Equipment Management Plan
7 pages
Vikash Kumar: Rail Land Development Authority
No ratings yet
Vikash Kumar: Rail Land Development Authority
254 pages
Accelerated Weathering Tester Operating Manual: Model: QUV/spray
No ratings yet
Accelerated Weathering Tester Operating Manual: Model: QUV/spray
51 pages
VB Notes
50% (2)
VB Notes
14 pages
Sorin CP Product Catalog
67% (3)
Sorin CP Product Catalog
70 pages
LPP Transportation Problem
No ratings yet
LPP Transportation Problem
39 pages
TR Biomedical Equipment Services NCII
No ratings yet
TR Biomedical Equipment Services NCII
90 pages
Electrical Safety and Performance Assessment of Medical Electrical Equipment Used in The Practice of Anesthesia.
100% (2)
Electrical Safety and Performance Assessment of Medical Electrical Equipment Used in The Practice of Anesthesia.
26 pages
Management of Clinical Alarm, 2024
No ratings yet
Management of Clinical Alarm, 2024
50 pages
TR Biomedical Equipment Servicing NC II
100% (1)
TR Biomedical Equipment Servicing NC II
69 pages
Package N 16A: UNIT - 6300 Common Etp Unit
No ratings yet
Package N 16A: UNIT - 6300 Common Etp Unit
3 pages
Grinding Technology HPGR
No ratings yet
Grinding Technology HPGR
6 pages
Edsin 51
No ratings yet
Edsin 51
34 pages
Hydraulic Systems: Understanding Truck-Mounted
No ratings yet
Hydraulic Systems: Understanding Truck-Mounted
44 pages
1 (1) - Pump
100% (1)
1 (1) - Pump
8 pages
Practical-1: CPU (Central Processing Unit)
No ratings yet
Practical-1: CPU (Central Processing Unit)
33 pages
JT DPS5005 Manual PDF
No ratings yet
JT DPS5005 Manual PDF
12 pages
Short Learning Topics On Biomedical Equipments
100% (1)
Short Learning Topics On Biomedical Equipments
37 pages
Ecg Simulator
100% (1)
Ecg Simulator
4 pages
Preview Copy: Healthcare Technology Management
100% (1)
Preview Copy: Healthcare Technology Management
19 pages
Lexus Brand Brochure
100% (1)
Lexus Brand Brochure
40 pages
Sist en 15048 1 2007
No ratings yet
Sist en 15048 1 2007
11 pages
CV Biomedical Engineer
No ratings yet
CV Biomedical Engineer
2 pages
w04 - SF - Medical Device Regulation V02
No ratings yet
w04 - SF - Medical Device Regulation V02
16 pages
Strategic Health Technology Incorporation
No ratings yet
Strategic Health Technology Incorporation
71 pages
ELEC 375 Introduction
No ratings yet
ELEC 375 Introduction
27 pages
02 Clinical Engineering
No ratings yet
02 Clinical Engineering
47 pages
Clinical Engineering
No ratings yet
Clinical Engineering
63 pages
02 Clinical Engineering
No ratings yet
02 Clinical Engineering
47 pages
Biyovent Ventilator Operating Manual 2021 2022 2
No ratings yet
Biyovent Ventilator Operating Manual 2021 2022 2
109 pages
Asme b3021 Masomenos Igual PDF
No ratings yet
Asme b3021 Masomenos Igual PDF
28 pages
Encyclopedia of Medical Devices and Instrumentation - Vol. 1
No ratings yet
Encyclopedia of Medical Devices and Instrumentation - Vol. 1
655 pages
GE MAC 2000 EKG Operators Manual
No ratings yet
GE MAC 2000 EKG Operators Manual
218 pages
2019 CBET Exam App 071819
No ratings yet
2019 CBET Exam App 071819
4 pages
Clinical Engineering in Brief
No ratings yet
Clinical Engineering in Brief
28 pages
Breathing Circuit Sets Unheated - Tech Specs - en - 689569.01
No ratings yet
Breathing Circuit Sets Unheated - Tech Specs - en - 689569.01
8 pages
User Manual - AMPLA 2085 - 0109
No ratings yet
User Manual - AMPLA 2085 - 0109
98 pages
OS-214plus/OS-2140D/ OS-2140/OS-2140Z/ OS-2140DZ/OS-2140E: Esktop Arcode Rinter
No ratings yet
OS-214plus/OS-2140D/ OS-2140/OS-2140Z/ OS-2140DZ/OS-2140E: Esktop Arcode Rinter
43 pages
Hospital Bio-Medical Technology, Services & Equipment
No ratings yet
Hospital Bio-Medical Technology, Services & Equipment
21 pages
اجهزة القياس PDF
No ratings yet
اجهزة القياس PDF
88 pages
Dräger Jaundice Meter JM-105 Sample Usage Protocol Template: Purpose
No ratings yet
Dräger Jaundice Meter JM-105 Sample Usage Protocol Template: Purpose
9 pages
HTM & Biomedical Engineering
No ratings yet
HTM & Biomedical Engineering
27 pages
Lecture No.
No ratings yet
Lecture No.
12 pages
Medical Equipment Management - Binseng Wang
No ratings yet
Medical Equipment Management - Binseng Wang
5 pages
Training Report by Anuj Sinha
No ratings yet
Training Report by Anuj Sinha
30 pages
Patient Monitor
No ratings yet
Patient Monitor
5 pages
Design and Simulation of Electrocardiogram Circuit
No ratings yet
Design and Simulation of Electrocardiogram Circuit
19 pages
Monique Frize-Ethics, Research Methods and Standards in Biomedical Engineering-Morgan & Claypool (2011)
No ratings yet
Monique Frize-Ethics, Research Methods and Standards in Biomedical Engineering-Morgan & Claypool (2011)
83 pages
ShaliDCT 102A
No ratings yet
ShaliDCT 102A
2 pages
Buku Biomedik
No ratings yet
Buku Biomedik
4 pages
Medtronic
No ratings yet
Medtronic
38 pages
Perfusore Space Manual
No ratings yet
Perfusore Space Manual
66 pages
Infusion Pumps Standards Guide
No ratings yet
Infusion Pumps Standards Guide
33 pages
Clinical Engineering Certification in The United States: Tobey Clark, CCE, University of Vermont, Burlington USA
No ratings yet
Clinical Engineering Certification in The United States: Tobey Clark, CCE, University of Vermont, Burlington USA
12 pages
Kudligi 03 WTGs Boq
No ratings yet
Kudligi 03 WTGs Boq
3 pages
CV Tobey Clark
No ratings yet
CV Tobey Clark
16 pages
2008 BIT MJ Medical Device Interfacing
No ratings yet
2008 BIT MJ Medical Device Interfacing
4 pages
Medicine Based Informatics and Engineering Complete Digital Book
No ratings yet
Medicine Based Informatics and Engineering Complete Digital Book
14 pages
Attachment: " How To Make Smart Walking Stick For Blind Person"
No ratings yet
Attachment: " How To Make Smart Walking Stick For Blind Person"
8 pages
Modpack Linki Oryginalne Puma145
No ratings yet
Modpack Linki Oryginalne Puma145
7 pages
Admit Card: Examination Centre: Centre Code
No ratings yet
Admit Card: Examination Centre: Centre Code
1 page
How To Prepare For The Certified Biomedical Equipment Technician (CBET) Exam?
No ratings yet
How To Prepare For The Certified Biomedical Equipment Technician (CBET) Exam?
19 pages
Introduction To Quantitative Decision-Making Methods in Healthcare Management
No ratings yet
Introduction To Quantitative Decision-Making Methods in Healthcare Management
16 pages
Biomedical Instrumentation Biomedical Instrumentation: Naydin@yildiz - Edu.tr
No ratings yet
Biomedical Instrumentation Biomedical Instrumentation: Naydin@yildiz - Edu.tr
7 pages
906 Release Info
No ratings yet
906 Release Info
3 pages
Managing Medical Devices MHRA
No ratings yet
Managing Medical Devices MHRA
34 pages
Future of Clinical Engineering - J.tobey Clark - 2003
No ratings yet
Future of Clinical Engineering - J.tobey Clark - 2003
10 pages
Free Hospital Equipment Inventory
No ratings yet
Free Hospital Equipment Inventory
8 pages

Health Care Engineering Part I: Clinical Engineering and Technology Management

Uploaded by

Health Care Engineering Part I: Clinical Engineering and Technology Management

Uploaded by

Series

Health Care Engineering

Lectures in Biomedical Engineering will be comprised of 75- to 150-page publications on

Health Care Engineering: Part I: Clinical Engineering and Technology Management

Computer-aided Detection of Architectural Distortion in Prior Mammograms of Interval Cancer

Chronobioengineering: Introduction to Biological Rhythms with Applications, Volume 1

Medical Equipment Maintenance: Management and Oversight

Fractal Analysis of Breast Masses in Mammograms

Ethics for Bioengineers

Computational Genomic Signatures

Analysis of Oriented Texture with Applications to the Detection of Architectural Distortion in

Biomedical Technology Assessment: The 3Q Method

Strategic Health Technology Incorporation

Phonocardiography Signal Processing

Introduction to Biomedical Engineering: Biomechanics and Bioelectricity - Part II

Introduction to Biomedical Engineering: Biomechanics and Bioelectricity - Part I

Landmarking and Segmentation of 3D CT Images

Basic Feedback Controls in Biomedicine

Understanding Atrial Fibrillation: The Signal Processing Contribution, Part II

Introductory Medical Imaging

Lung Sounds: An Advanced Signal Processing Perspective

An Outline of Informational Genetics

Neural Interfacing: Forging the Human-Machine Connection

Tremor: From Pathogenesis to Treatment

Introduction to Continuum Biomechanics

The Effects of Hypergravity and Microgravity on Biomedical Experiments

A Biosystems Approach to Industrial Patient Monitoring and Diagnostic Devices

Estimation of Cortical Connectivity in Humans: Advanced Signal Processing Techniques

Brain–Machine Interface Engineering

Introduction to Statistics for Biomedical Engineers

Capstone Design Courses: Producing Industry-Ready Biomedical Engineers

Fundamentals of Respiratory Sounds and Analysis

Advanced Probability Theory for Biomedical Engineers

Intermediate Probability Theory for Biomedical Engineers

Basic Probability Theory for Biomedical Engineers

Signal Processing of Random Physiological Signals

Image and Signal Processing for Networked E-Health Applications

Health Care Engineering: Part I: Clinical Engineering and Technology Management

ISBN: 9781608453665 print

A Publication in the Morgan & Claypool Publishers series

Series ISSN 1930-0328 Print 1930-0336 Electronic

SYNTHESIS LECTURES ON BIOMEDICAL ENGINEERING #50

2 Measuring Physiological Variables in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . ���9

3 Management of Medical Technologies in Industrialized and Developing

4 Safety Considerations, Minimizing Liability, and Continuous Quality

5 Telemedicine: Applications and Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  59

The Health Care System in North

1.1.1 SOME HISTORICAL FACTS

1.2 UNITED STATES

1.3 COVERAGE AND ACCESS

1.4 HEALTH CARE FACILITIES

OTHER SUGGESTED READING

Measuring Physiological Variables in

2.1 COMMON MEASUREMENTS OF PHYSIOLOGICAL

2.1.1 THE HEART

Signal Conditioning for the ECG

2.1.2 NON-INVASIVE BLOOD PRESSURE MEASUREMENTS (NIBP)

2.1.3 INVASIVE BLOOD PRESSURE

2.1.5 PACING THE HEART

Figure 2.4: Pacing the heart. (Source: http://en.wikipedia.org/wiki/File:Conductionsystemofthe-

Figure 2.5: Typical pacemaker and leads. (Source: http://en.wikipedia.org/wiki/File:St_Jude_Medi-

2.1.6 THE BRAIN

Figure 2.6: International electrode configuration for EEG. (Source: http://en.wikipedia.org/wiki/

2.1.7 ELECTROMYOGRAPHY (EMG)

Figure 2.7: Rip bands to measure respiration cycle. (Source: http://en.wikipedia.org/wiki/Respira-

Figure 2.8: Incubator for premature infants. (Source: http://www.sciencephoto.com/im-

2.2.1 CHARACTERISTICS OF PHYSICAL SENSORS

The Transfer Function

Resolution is defined as the smallest detectable input quantity change.

Micro-Total Analysis System (µTAS)

OTHER SUGGESTED READING

3.1 EVOLUTION OF CLINICAL ENGINEERING IN

3.2 FUNCTIONS AND ACTIVITIES OF CLINICAL

3.2.1 IN-HOUSE MEDICAL EQUIPMENT MAINTENANCE

3.2.2 FUNCTIONS USUALLY PERFORMED BY ENGINEERS

Investigation of Incidents or Accidents

2 Measuring Physiological Variables in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . ��9

5 Telemedicine: Applications and Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59